510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2021 DEVICE: Electric Wheelchair [Models: JRWD6010/JRWD6012] Jerry Medical Instrument (Shanghai510(k) NO: K192739(Traditional) ATTN: Jianguo Chen PHONE NO : 86 138 17397985 Building 12, No. 615 Fengdeng Rd, SE DECISION MADE: 13-JUL-21 Shanghai CN 201801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nebulizer Kit Excellentcare Medical (Huizhou) Lt510(k) NO: K192971(Traditional) ATTN: Chunyu Zhao PHONE NO : 86 752 6358312 Shatou Industrial Zone. Yuanzhou TSE DECISION MADE: 08-JUL-21 Huizhou CN 516123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Pro510(k) NO: K193047(Traditional) ATTN: Christine Perkins PHONE NO : 302 6318811 Emil-von-Behring-Str. 76 SE DECISION MADE: 14-JUL-21 Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AbutmentCAD exocad GmbH 510(k) NO: K193352(Traditional) ATTN: Stefan Walter PHONE NO : 49 6151 629489 0 37, Julius-Reiber-Str. SE DECISION MADE: 21-JUL-21 Darmstadt DE 64293 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Centaur® Digoxin assay Siemens Healthcare Diagnostics, In510(k) NO: K193397(Traditional) ATTN: Anoop Joy PHONE NO : 914 5242273 511 Benedict Avenue SE DECISION MADE: 16-JUL-21 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SensiTox C. difficile Toxin Test First Light Diagnostics, Inc. 510(k) NO: K193490(Traditional) ATTN: Joanne Spadoro PHONE NO : 781 2710112 2 Omni Way SE DECISION MADE: 08-JUL-21 Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIOCLEAR System Perfection Aligner System Hong Kon510(k) NO: K193622(Traditional) ATTN: Alwin Ngai PHONE NO : 852 3766 0737 Flat/Rm 4B, 4/F, Hang Fat IndustriSE DECISION MADE: 06-JUL-21 Kowloon, HongKong HK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Crosstex VH2O2 Chemical Indicators Crosstex International, Inc. (A Ca510(k) NO: K200096(Special) ATTN: Pablo Martinez PHONE NO : 800 7221529 6789 W. Henrietta Road SE DECISION MADE: 15-JUL-21 Rush NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OncoMate MSI Dx Analysis System Promega Corporation 510(k) NO: K200129(Traditional) ATTN: Ron Wheeler PHONE NO : 608 2744330 2800 Woods Hollow Rd SE DECISION MADE: 26-JUL-21 Madison WI 53711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Centaur® Total hCG assay Siemens Healthcare Diagnostics, In510(k) NO: K200210(Traditional) ATTN: Mey Lyn Vasquez PHONE NO : 914 5242458 511 Benedict Ave. SE DECISION MADE: 13-JUL-21 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, In510(k) NO: K200256(Special) ATTN: Julie Warren PHONE NO : 302 6318722 511 Benedict Avenue SE DECISION MADE: 02-JUL-21 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM TRUEMED GROUP LLC 510(k) NO: K200575(Traditional) ATTN: Nina Galeana Rodriguez PHONE NO : 713 8583189 2002 Timberloch Place Suite 200 SE DECISION MADE: 09-JUL-21 The Woodlands TX 77380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mini PCNL-System Trokamed GmbH 510(k) NO: K200770(Traditional) ATTN: Stefan Weiland PHONE NO : 49 07704 924451 Kleine Breite 17 SE DECISION MADE: 30-JUL-21 Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs GX Corporation Sdn Bhd 510(k) NO: K200915(Traditional) ATTN: Khon Pu Foo PHONE NO : 60 03 32915788 Lot 6491 Batu 5 3/4, Sementa JalanSE DECISION MADE: 09-JUL-21 Klang MY 42100 510(k) STATEMENT DEVICE: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine Ningbo Hesi Electric Co., Ltd 510(k) NO: K200983(Traditional) ATTN: Ma LuLu PHONE NO : 86 158255 67078 No.818-23-156 Qiming Rd, Yinzhou, SE DECISION MADE: 14-JUL-21 Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHIRAVAC Blood Collection Needles CHIRANA T. Injecta 510(k) NO: K201009(Traditional) ATTN: Zdenka Klbeckova PHONE NO : 421 32 7709972 Nàm. Dr. Schweitzera 194 SE DECISION MADE: 21-JUL-21 Starà Turà SK 916 01 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bio-Medicus Life Support Catheter and Introducer Medtronic Inc. 510(k) NO: K201100(Traditional) ATTN: Juli Rubin PHONE NO : 763 5262357 8200 Coral Sea St. NE SE DECISION MADE: 15-JUL-21 Mounds Views MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elos® Intramedullary Nailing System Intrauma S.p.A. 510(k) NO: K201147(Traditional) ATTN: Piero Costa PHONE NO : 39 011 9539496 Via Genova 19 SE DECISION MADE: 19-JUL-21 Rivoli (TO) IT 10098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) M.I. Tech Co., Ltd 510(k) NO: K201160(Traditional) ATTN: Inae Kim PHONE NO : 82 70 43047450 174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 23-JUL-21 Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Microwave Therapeutic System Nanjing ECO Microwave System Co., 510(k) NO: K201262(Traditional) ATTN: Hong Wei PHONE NO : 86 025 58872663 Third & Fourth Floors, J5 BuildingSE DECISION MADE: 09-JUL-21 Nanjing CN 211800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Microwave Therapeutic Antennas Nanjing ECO Microwave System Co., 510(k) NO: K201265(Traditional) ATTN: Hong Wei PHONE NO : 86 25588 72663 Third & Fourth Floors, J5 BuildingSE DECISION MADE: 23-JUL-21 Nanjing CN 211800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair Psychemedics Corporation 510(k) NO: K201326(Traditional) ATTN: Neil Stowe PHONE NO : 310 2167776 5832 Uplander Way SE DECISION MADE: 27-JUL-21 Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. 510(k) NO: K201328(Traditional) ATTN: Maryam Amini PHONE NO : 858 2036715 6310 Sequence Dr. SE DECISION MADE: 15-JUL-21 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ExoAtlet-II ExoAtlet Asia Co. Ltd. 510(k) NO: K201473(Traditional) ATTN: Bret Bostock PHONE NO : 720 4751826 4582 S. Ulster Streer, Suite 205 SE DECISION MADE: 16-JUL-21 Denver CO 80237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads Corin Ltd. 510(k) NO: K201657(Traditional) ATTN: Christina Rovaldi PHONE NO : 800 4486664 480 Paramount Drive SE DECISION MADE: 28-JUL-21 Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) bioMerieux, Inc. 510(k) NO: K201675(Traditional) ATTN: Debra Broyles PHONE NO : 314 7318805 595 Anglum Road SE DECISION MADE: 09-JUL-21 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KDL Micro catheter Shanghai Kindly Medical Instrument510(k) NO: K201706(Traditional) ATTN: Xu Jianhai PHONE NO : 86 21591 400568870 No. 925, Jinyuan yi Road SE DECISION MADE: 22-JUL-21 Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arterial Catheter Haolang Medical USA Corporation 510(k) NO: K201726(Traditional) ATTN: Lisa Xu PHONE NO : 425 5036325 1100 Bellevue Way NE 8A-533 SE DECISION MADE: 07-JUL-21 Bellevue WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Provident II Hip Stems Globus Medical Inc. 510(k) NO: K201733(Special) ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861 2560 General Armistead Ave. SE DECISION MADE: 14-JUL-21 Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hydrozid MediLink A/S 510(k) NO: K201740(Traditional) ATTN: Cristina Teixeira PHONE NO : 45 306 66502 Gammelmosevej 176A SE DECISION MADE: 07-JUL-21 Kgs. Lyngby DK 2800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care Inc. 510(k) NO: K201761(Traditional) ATTN: Ono Bacani PHONE NO : 510 2392622 1360 South Loop Road SE DECISION MADE: 30-JUL-21 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-SURE Lazarus, 3D, Inc 510(k) NO: K201835(Traditional) ATTN: Smriti Zanevald PHONE NO : 541 7601805 3513 NW Mink Pl SE DECISION MADE: 08-JUL-21 Corvallis OR 97330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Face Mask, Surgical Mask Lear Corporation 510(k) NO: K201844(Abbreviated) ATTN: Ryan Facer PHONE NO : 336 3418687 1 Penn Dye St SE DECISION MADE: 14-JUL-21 Pine Grove PA 17963 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VS Newborn Heart Rate Monitor SurePulse Medical Limited 510(k) NO: K201887(Traditional) ATTN: James Carpenter PHONE NO : 44 0333 5771133 Medicity, D6 Thane Road SE DECISION MADE: 23-JUL-21 Nottingham GB NG90 gbh 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable IV catheter Shinva Ande Healthcare Apparatus C510(k) NO: K202060(Traditional) ATTN: Liang Wanjie PHONE NO : 86 533 3917816 No.77 Development Zone North Road SE DECISION MADE: 23-JUL-21 Zibo CN 255086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EliA SmDP-S Phadia AB 510(k) NO: K202067(Traditional) ATTN: Carina Magnusson PHONE NO : 46 18 165000 Rapsgatan 7P SE DECISION MADE: 14-JUL-21 Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pulmogine Vibrating Mesh Nebulizer HCMed Innovations Co., Ltd. 510(k) NO: K202171(Traditional) ATTN: Yiling Lee PHONE NO : 886 2 27326596 51 Rm.B, 10F, No.319, Sec.2, Dunhua SSE DECISION MADE: 01-JUL-21 Taipei City TW 10669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BeneHold Surgical Incise Drape with CHG antimicrobial Avery Dennison Belgie BVBA 510(k) NO: K202208(Traditional) ATTN: Lisa Bartakovics PHONE NO : 1 312 2066159 Tieblokkenlaan, 1 SE DECISION MADE: 30-JUL-21 Turnhout BE 2300 510(k) STATEMENT DEVICE: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) Hamilton Thorne, Inc. 510(k) NO: K202241(Traditional) ATTN: Donald Fournier PHONE NO : 978 9212050 100 Cummings Center, Suite 465E SE DECISION MADE: 02-JUL-21 Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Forehead Thermometer, Model BSX976 Shenzhen BSX Technology Electronic510(k) NO: K202296(Traditional) ATTN: Lijuan Du PHONE NO : 86 755 28719103 Rm301.3F 8th Building, LiHao IndusSE DECISION MADE: 23-JUL-21 Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) NYU Langone Medical Center 510(k) NO: K202304(Third Party - Traditional) ATTN: Matija Snuderl PHONE NO : 646 5015281 240 E 38th Street SE DECISION MADE: 14-JUL-21 New York NY 10016 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: Aduro Light Beauty Mask Shenzhen Kaiyan Medical Co Ltd 510(k) NO: K202390(Traditional) ATTN: Alain Dijkstra PHONE NO : 86 135 103787481 40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 14-JUL-21 Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cytrellis Dermal Micro-Coring System Cytrellis Biosystems, Inc. 510(k) NO: K202517(Traditional) ATTN: Karen H. Cronholm PHONE NO : 857 2541720 299C Washington St SE DECISION MADE: 09-JUL-21 Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Insulin Syringe, Insulin Syringe with Safety Retractable Jiangsu Micsafe Medical Technology510(k) NO: K202570(Traditional) ATTN: Tony Yang PHONE NO : 086 1365 1929266 Xituan Industrial Park, Dafeng DisSE DECISION MADE: 02-JUL-21 Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TruAbutment DS, TruBase TruAbutment Inc. 510(k) NO: K202579(Traditional) ATTN: Eunjin Jang PHONE NO : 714 9561488 17742 Cowan SE DECISION MADE: 08-JUL-21 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex SynergyID Endoscopic Imaging System Arthrex Inc. 510(k) NO: K202582(Traditional) ATTN: Heli F. Chambi Infantas PHONE NO : 239 6435553 71263 1370 Creekside Boulevard SE DECISION MADE: 22-JUL-21 Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Temp Pal iWEECARE Co., Ltd. 510(k) NO: K202603(Traditional) ATTN: Glen Tseng PHONE NO : 886 2 28213597 2F, No. 121, Sec. 2, Linong St., BSE DECISION MADE: 22-JUL-21 Taipei City TW 112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) Thermo Fisher Scientific 510(k) NO: K202612(Traditional) ATTN: Cynthia Knapp PHONE NO : 1 800 8718909 One Thermo Fisher Way SE DECISION MADE: 23-JUL-21 Oakwood Village OH 44146 510(k) STATEMENT DEVICE: Pain Therapy Device Guangzhou Xinbo Electronic Co., Lt510(k) NO: K202638(Traditional) ATTN: Sammy Li PHONE NO : 86 20 66393598 No.23 Building, The Second Phase, SE DECISION MADE: 15-JUL-21 Guangzhou CN 511450 510(k) STATEMENT DEVICE: Peregrine Endoscopy System 3NT Medical Ltd. 510(k) NO: K202727(Traditional) ATTN: Ehud Bendory PHONE NO : 972 73 7154056 22 HaMelacha St., POB 11384 SE DECISION MADE: 23-JUL-21 Rosh Ha'Ayin IL 4809169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Forehead Thermometer Shenzhen Combei Technology Co., Lt510(k) NO: K202741(Traditional) ATTN: Kevin Fong PHONE NO : 086 755 29588956 No. 105, Huanguan South Road, DaheSE DECISION MADE: 07-JUL-21 Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sectum Neauvia North America 510(k) NO: K202780(Traditional) ATTN: Misty Williams PHONE NO : 984 7775292 8480 Honeycutt Road SE DECISION MADE: 30-JUL-21 Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTI Extra-Short Dental Implant System UnicCa B.T.I. Biotechnology Institute, S.510(k) NO: K202825(Traditional) ATTN: Jose Roman Rivero PHONE NO : 34 945 297030 Leonardo da Vinci 14, Parque TecnoSE DECISION MADE: 29-JUL-21 Minano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERA HARZ Graphy Inc. 510(k) NO: K202846(Traditional) ATTN: Tae-woo Kim PHONE NO : 82 33 7480433 1607, Gasan SK V1 Center, 171, GasSE DECISION MADE: 15-JUL-21 Seoul KR 08503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LifeSignals Multi-Parameter Remote Monitoring Platform LifeSignals, Inc. 510(k) NO: K202868(Traditional) ATTN: Saravanan Balasubramanian PHONE NO : 510 7706412 4 39355 California Street, Suite 305SE DECISION MADE: 21-JUL-21 Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoSync™ Ti Dental Mesh Sites Medical, LLC 510(k) NO: K202918(Traditional) ATTN: Greg Stalcup PHONE NO : 260 6253347 5865 E State Road 14 SE DECISION MADE: 14-JUL-21 Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: END 200 Endoscopic Tubeset Palliare Ltd. 510(k) NO: K202922(Traditional) ATTN: John O’Dea PHONE NO : 353 91 516362 Galway Business Park, Dangan SE DECISION MADE: 08-JUL-21 Galway IE H91 P2DK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Surgical Mask Xiamen Probtain Medical Techology 510(k) NO: K202954(Traditional) ATTN: Jianli Kang PHONE NO : 86 592 7557106 4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 02-JUL-21 Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Myopia Master OCULUS Optikgeräte GmbH 510(k) NO: K202989(Traditional) ATTN: Eckhard Loh PHONE NO : 49 641 20050 Münchholzhäuser Straße 29 SE DECISION MADE: 14-JUL-21 Wetzlar DE 35582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pantheon IBFD Pantheon Spinal 510(k) NO: K203003(Special) ATTN: Dave Lamb PHONE NO : 512 3043488 40132 Industrial Park Circle SuiteSE DECISION MADE: 07-JUL-21 Georgetown TX 78626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pisces Spinal System Ortho Development Corporation 510(k) NO: K203023(Traditional) ATTN: Divya Palan PHONE NO : 810 6198922 12187 South Business Park Drive SE DECISION MADE: 14-JUL-21 Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ignite Stemless Anatomic Shoulder System Ignite Orthopedics LLC 510(k) NO: K203108(Traditional) ATTN: Matt Purdy PHONE NO : 612 2145361 700 Park Avenue Suite F SE DECISION MADE: 16-JUL-21 Winona Lake IN 46590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARVIS Surgical Navigation System Insight Medical Systems Inc. 510(k) NO: K203115(Traditional) ATTN: Nicholas R. van der Walt PHONE NO : 858 2259882 25892 La Cuesta Avenue SE DECISION MADE: 14-JUL-21 Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) Ningbo Youhe Electrical Appliance 510(k) NO: K203148(Traditional) ATTN: Huang Yun Jun PHONE NO : 86 574 63860315 No.567, Xintang Road, Fuhai Town SE DECISION MADE: 08-JUL-21 Cixi CN 315322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioWave BioWraps BioWave Corporation 510(k) NO: K203158(Traditional) ATTN: Bradford Siff PHONE NO : 203 6357175 8 Knight Street, Suite 201 SE DECISION MADE: 08-JUL-21 Norwalk CT 06851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LifeLens Wireless ECG Monitor LifeLens Technologies, Inc. 510(k) NO: K203168(Traditional) ATTN: Landy Toth PHONE NO : 215 6224715 1 Ivybrook Blvd, Suite 115 SE DECISION MADE: 20-JUL-21 Ivyland, Bucks PA 18974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARSTEM Cemented Femoral Stem Smith & Nephew, Inc. 510(k) NO: K203175(Traditional) ATTN: Brad Sheals PHONE NO : 901 2887141 7135 Goodlett Farms Parkway SE DECISION MADE: 22-JUL-21 Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ Metal Sterilization Trays Karl Storz Endoscopy America Inc 510(k) NO: K203198(Traditional) ATTN: Leigh Spotten PHONE NO : 424 2188376 2151 E Grand Ave SE DECISION MADE: 06-JUL-21 El Segundo CA 90245-5017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DemarkQ WOW, DemarkQ POP Shenzhen Kaiyan Medical Co Ltd 510(k) NO: K203214(Traditional) ATTN: Alain Dijkstra PHONE NO : 86 755 82129361 40A Fuxin Road Fuyong Subdistrict SE DECISION MADE: 22-JUL-21 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform Edwards Lifesciences, LLC 510(k) NO: K203224(Traditional) ATTN: Lisa Gilman PHONE NO : 949 2501478 One Edwards Way SE DECISION MADE: 30-JUL-21 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cannula for Organ Perfusion Bridge to Life Ltd. 510(k) NO: K203262(Traditional) ATTN: Brett Schultz PHONE NO : 847 7963070 128 Suber Rd., Suite A SE DECISION MADE: 01-JUL-21 Columbia SC 29210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aduro light therapy Handheld Shenzhen Kaiyan Medical CO LTD 510(k) NO: K203271(Traditional) ATTN: Alain Dijkstra PHONE NO : 86 755 82129361 40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 21-JUL-21 Shenzhen CN 518000 510(k) STATEMENT DEVICE: NUVO CF Implant System JJGC Indústria e Comércio de Mater510(k) NO: K203309(Traditional) ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000 Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 06-JUL-21 Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask Suzhou Yuyue Medical Technology Co510(k) NO: K203347(Traditional) ATTN: Sun Wei PHONE NO : 86 512 67373001 No. 9 Jinfeng Road, Suzhou ScienceSE DECISION MADE: 02-JUL-21 Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD Flu+ Syringe Becton, Dickinson and Company 510(k) NO: K203359(Traditional) ATTN: Nikita Abirami Mahendra KumaPHONE NO : 201 8475641 1 Becton Drive SE DECISION MADE: 28-JUL-21 Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avance Solo Negative Pressure Wound Therapy (NPWT) System Molnlycke Health Care US, LLC 510(k) NO: K203369(Traditional) ATTN: Megan Bevill PHONE NO : 770 5479196 5445 Triangle Parkway Suite 400 SE DECISION MADE: 01-JUL-21 Peachtree Corners GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Summit Patella Plating System Endeavor Orthopaedics, LLC 510(k) NO: K203408(Traditional) ATTN: John Alleman PHONE NO : 217 7210758 11601 S Richmond Avenue SE DECISION MADE: 30-JUL-21 Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.CT Skull Unfolding Siemens Medical Solutions USA, Inc510(k) NO: K203411(Traditional) ATTN: Tabitha Estes PHONE NO : 865 8044553 810 Innovation Drive SE DECISION MADE: 22-JUL-21 Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Ear Thermometer Probe Cover Huaian Zhongxin Packing Material C510(k) NO: K203431(Traditional) ATTN: Feng Zuo PHONE NO : 86 15 751384913 No. 128-5, West Meigao Road, QingpSE DECISION MADE: 28-JUL-21 Huaian CN 223022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Axium Detachable Coil; Axium Prime Detachable Coil Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K203432(Traditional) ATTN: Bhavika Patel PHONE NO : 949 4345030 5290 California Ave SE DECISION MADE: 07-JUL-21 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System Nihon Kohden Corporation 510(k) NO: K203435(Traditional) ATTN: Sandra Gadeyne PHONE NO : 949 3563401 1-31-4 Nishiochiai, Shinjuku-Ku SE DECISION MADE: 16-JUL-21 Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Alma Hybrid Laser System Alma Lasers, Ltd. 510(k) NO: K203441(Traditional) ATTN: Avi Hirshnzon PHONE NO : 972 54 3303402 18 Haharash Street, North IndustriSE DECISION MADE: 02-JUL-21 Caesarea Ha Zafon IL 3079895 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SafeCross Transseptal Puncture and Introducer (TSP/I) System East End Medical I LLC 510(k) NO: K203459(Traditional) ATTN: Brij Maini PHONE NO : 717 6450809 1157 Sawgrass Corporate Parkway SE DECISION MADE: 06-JUL-21 Sunrise FL 33323 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nexo-Gide Bilayer Collagen Membrane Geistlich Pharma AG 510(k) NO: K203496(Traditional) ATTN: Marco Steiner PHONE NO : 41 41 4926764 Bahnhofstrasse 40 SE DECISION MADE: 14-JUL-21 Wolhusen CH 6110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LX9max Daesung Maref CO., LTD. 510(k) NO: K203498(Traditional) ATTN: Su Hyeon So PHONE NO : 82 31 4597211 298-24, Gongdan-Ro SE DECISION MADE: 02-JUL-21 Gunpo-Si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART FINDER IMS Giotto S.p.A. 510(k) NO: K203509(Special) ATTN: Antonella Rossi PHONE NO : 39 051 846851 VIA Sagittario, 5 SE DECISION MADE: 14-JUL-21 Sasso Marconi IT 40037 510(k) STATEMENT DEVICE: Surgical face mask (Model: Flat Ear Loop/CN102) Crown Name Disposable Hygiene Prod510(k) NO: K203534(Traditional) ATTN: Ying Fang PHONE NO : 86 027 82761940 Chengbei Industrial Zone, ZhuchengSE DECISION MADE: 21-JUL-21 Wuhan CN 431400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables Medtronic , Inc. 510(k) NO: K203556(Traditional) ATTN: Alexandra Theisen PHONE NO : 763 5266758 8200 Coral Sea Street NE SE DECISION MADE: 12-JUL-21 Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Finetest Lite Blood Glucose Monitoring System Osang Healthcare Co., Ltd. 510(k) NO: K203562(Special) ATTN: Ik-Hyeon Kim PHONE NO : 82 31 4600415 132, Anyangcheondong-Ro, Dongan-GuSE DECISION MADE: 13-JUL-21 Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GlidePath Retro Long-Term Hemodialysis Catheter C.R. Bard, Inc. 510(k) NO: K203575(Traditional) ATTN: Joan Bergstrom PHONE NO : 480 5978425 1625 W. Third Street SE DECISION MADE: 01-JUL-21 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single-use Medical Face Mask Conod Medical Co., Limited 510(k) NO: K203591(Traditional) ATTN: Carrie Wu PHONE NO : 86 0512 52306320 No.11 Hongfeng Road, Baimao IndustSE DECISION MADE: 02-JUL-21 Changshu CN 215532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iSR'obot Mona Lisa 1.0 Biobot Surgical Pte Ltd 510(k) NO: K203659(Traditional) ATTN: Lim Yan Shin PHONE NO : 65 97263992 2 Woodlands Spectrum l, #03-10 WooSE DECISION MADE: 08-JUL-21 Singapore SG 738068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAZIC Claro CAD and MAZIC Claro Press Vericom Co., Ltd. 510(k) NO: K203672(Traditional) ATTN: Yun Ki Kim PHONE NO : 82 31 4412881 48, Toegyegongdan 1-Gil, SE DECISION MADE: 01-JUL-21 Chuncheon-Si KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELTA XTEND Reverse Shoulder System DePuy Ireland UC 510(k) NO: K203694(Traditional) ATTN: Jaclyn Cincotta PHONE NO : Loughbeg, Ringaskiddy SE DECISION MADE: 22-JUL-21 Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 Oxoid Limited (Part of Thermo Fish510(k) NO: K203700(Traditional) ATTN: Philip Brame PHONE NO : 44 0 7884332059 Wade Road SE DECISION MADE: 30-JUL-21 Basingstroke GB RG24 8PW 510(k) STATEMENT DEVICE: The Slide Biotex, Inc. 510(k) NO: K203712(Traditional) ATTN: Wade Munsch PHONE NO : 713 7410111 208 114 Holmes Rd. SE DECISION MADE: 20-JUL-21 Houston TX 77045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Darwin Luvo Medical Technologies, Inc 510(k) NO: K203728(Traditional) ATTN: Gregory Berzak PHONE NO : 519 6203900 125 Fleming Drive SE DECISION MADE: 14-JUL-21 Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Straumann Surgical Cassettes Straumann USA, LLC 510(k) NO: K203753(Traditional) ATTN: Chanrasmey White PHONE NO : 978 7472614 60 Minuteman Road SE DECISION MADE: 29-JUL-21 Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray Zirkonzahn SRL 510(k) NO: K203765(Traditional) ATTN: Julian Steger PHONE NO : 39 0474 066660 Via An der Ahr 7 SE DECISION MADE: 20-JUL-21 Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Firefly Needleless Connector PuraCath Medical, Inc 510(k) NO: K203796(Traditional) ATTN: Julia Rasooly PHONE NO : 415 3054134 37600 Central Court, Suite 210 SE DECISION MADE: 30-JUL-21 Newark CA 94560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SyntrFuge System Syntr Health Technologies, Inc. 510(k) NO: K203800(Traditional) ATTN: Ahmed Zobi PHONE NO : 949 7324298 5270 California Ave., Suite #300 SE DECISION MADE: 02-JUL-21 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JS Dental Lab Mouth Guard Ampower Dental Laboratories, LLC 510(k) NO: K210011(Traditional) ATTN: Dylan Hao PHONE NO : 510 7408418 3423 Investment Blvd Suite 11 HaywSE DECISION MADE: 16-JUL-21 Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tamarin Blue PTCA RX Dilatation Catheter Natec Medical Ltd. 510(k) NO: K210012(Special) ATTN: Roy Devassy Pallippatt PHONE NO : 230 466 3065 Maeva Centra Building, Silicon AveSE DECISION MADE: 09-JUL-21 Reduit MU 72201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System Integra Lifesciences Corporation 510(k) NO: K210016(Traditional) ATTN: Blesson Abraham PHONE NO : 512 3681423 11101 Metric Blvd SE DECISION MADE: 27-JUL-21 Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Promisemed Insulin Pen Needle Promisemed Hangzhou Meditech Co., 510(k) NO: K210059(Traditional) ATTN: Zearou Yang PHONE NO : 86 571 88772985 No. 1388 Cangxing Street, CangqianSE DECISION MADE: 21-JUL-21 Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Estar-Z Osstem Implant Co., Ltd. 510(k) NO: K210097(Traditional) ATTN: Jungmin Yoo PHONE NO : 82 70 43949670 A-dong, 51, Mayu-ro 238beon-gil SE DECISION MADE: 02-JUL-21 Siheung-si KR 15079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX Lifelong Meditech Private Limited 510(k) NO: K210103(Traditional) ATTN: Hamendra Nath Srivastava PHONE NO : 91 12 44406600 Plot No.18, Sector-5, IMT Manesar SE DECISION MADE: 16-JUL-21 Gurugram IN 122050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SurroundScope System 270Surgical Ltd. 510(k) NO: K210104(Traditional) ATTN: Avi Levy PHONE NO : 972 779 031100 4 Arie Regev Street SE DECISION MADE: 08-JUL-21 Netanya IL 4250212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FiteBac CC OrthoSeal Largent Health, LLC 510(k) NO: K210115(Traditional) ATTN: Kirk Kimmerling PHONE NO : 770 2186221 3698 Largent Way NW, Suite 101 SE DECISION MADE: 29-JUL-21 Marietta GA 30064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iQ200 System, iChemVELOCITY Automated Urine Chemistry System Beckman Coulter, Inc. 510(k) NO: K210127(Traditional) ATTN: Marisa Pugliese PHONE NO : 305 3803002 11800 SW 147th Ave SE DECISION MADE: 02-JUL-21 Miami FL 33196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RF Thermal System Luvo Medical Technologies, Inc 510(k) NO: K210129(Traditional) ATTN: Gregory Berzak PHONE NO : 519 6203900 125 Fleming Drive SE DECISION MADE: 20-JUL-21 Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) Foshan Nanhai Plus Medical CO LTD 510(k) NO: K210143(Traditional) ATTN: Eric Li PHONE NO : 086 757 86914198 Shatou Jiujiang Town, Nanhai DistrSE DECISION MADE: 22-JUL-21 Foshan CN 528200 510(k) STATEMENT DEVICE: Labat series Diagnostic Ultrasound System Shenzhen Wisonic Medical Technolog510(k) NO: K210154(Traditional) ATTN: Jiang Xiaosan PHONE NO : 86 755 86007788 1st, 2nd, 5th & 6th Floor, NO.6 BuSE DECISION MADE: 30-JUL-21 Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IntraLock System Fusion Orthopedics, LLC 510(k) NO: K210159(Traditional) ATTN: Whitney Rey PHONE NO : 800 4036876 4135 S. Powder Rd., Suite 110 SE DECISION MADE: 23-JUL-21 Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FlowSaver Blood Filter Inari Medical 510(k) NO: K210176(Traditional) ATTN: Eben Gordon PHONE NO : 949 4184095 9 Parker, Suite 100 SE DECISION MADE: 22-JUL-21 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CardioCurve Steerable Sheath Talon Surgical 510(k) NO: K210185(Traditional) ATTN: Jay Muse PHONE NO : 801 2102886 6030 West Harold Gatty Drive SE DECISION MADE: 23-JUL-21 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PacBond One Pac-Dent, Inc. 510(k) NO: K210186(Traditional) ATTN: Tom Peng PHONE NO : 909 8390888 670 Endeavor Circle SE DECISION MADE: 16-JUL-21 Brea CA 92821 510(k) STATEMENT DEVICE: Pac-Dent Denture Base Resin Pac-Dent, Inc. 510(k) NO: K210189(Traditional) ATTN: Jingtian Peng PHONE NO : 909 8390888 111 670 Endeavor Circle SE DECISION MADE: 28-JUL-21 Brea CA 92821 510(k) STATEMENT DEVICE: RICOH MEG Ricoh Company, Ltd. 510(k) NO: K210199(Traditional) ATTN: Satoshi Yuuki PHONE NO : 81 76 2587012 2-3, Hokuyodai SE DECISION MADE: 02-JUL-21 Kanazawa-shi JP 920-0177 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Gowns Jiangsu Province Jianerkang Medica510(k) NO: K210215(Traditional) ATTN: Tang Hongfang PHONE NO : 86 135 85416869 No.1 Jianerkang Road, Zhixi IndustSE DECISION MADE: 07-JUL-21 Changzhou CN 213251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Medical Face Mask Suzhou Bolisi Medical Technology C510(k) NO: K210244(Traditional) ATTN: Hong Xu PHONE NO : 86 137 76246881 Baijiaqiao industrial community, YSE DECISION MADE: 12-JUL-21 Zhangjiagang CN 215000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lab Bag with Fabric Pouch Advanced Medical Design Co., Ltd. 510(k) NO: K210248(Traditional) ATTN: Silvia Yeh PHONE NO : 886 2 22902627 511 4-5F, No 29, Wuquan 5th Rd., Wugu SE DECISION MADE: 30-JUL-21 New Taipei City TW 248018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PowerPiCC Catheter Bard Access Systems, Inc. 510(k) NO: K210264(Traditional) ATTN: Mary Strickland PHONE NO : 801 5225000 605 North 5600 West SE DECISION MADE: 30-JUL-21 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Surgical Mask Xiamen Eagledon Pharmaceutical Co.510(k) NO: K210267(Traditional) ATTN: Aggie Zhang PHONE NO : 86 592 7231999 No.220-228, Meihe 3rd Road SE DECISION MADE: 08-JUL-21 Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fingertip Pulse Oximeter Zhuhai Linte Medical Instrument Co510(k) NO: K210274(Traditional) ATTN: Kezheng Ma PHONE NO : 86 135 30230360 4th Floor, Building 1, No.66, YongSE DECISION MADE: 30-JUL-21 Zhuhai CN 519090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. Shenzhen Mismon Technology Co., Lt510(k) NO: K210311(Traditional) ATTN: Rain Yip PHONE NO : 86 188 14498433 4th Floor, Building B, Zone A, LonSE DECISION MADE: 23-JUL-21 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bravo G4 Chamber Autoclave SciCan Ltd. 510(k) NO: K210326(Abbreviated) ATTN: Teresa Boyce PHONE NO : 416 4462783 1440 Don Mills Road SE DECISION MADE: 01-JUL-21 Toronto CA M3B 3P9 510(k) STATEMENT DEVICE: TKO Composite Bite Turbo Gel Reliance Orthodontic Products, Inc510(k) NO: K210349(Traditional) ATTN: Christine Cook PHONE NO : 800 3234348 1540 W Thorndale Ave SE DECISION MADE: 20-JUL-21 Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Broncho Videoscope System Scivita Medical Technology Co., Lt510(k) NO: K210379(Traditional) ATTN: Ruqin Wu PHONE NO : 86 512 81877788 No.8, ZhongTian Xiang, Suzhou InduSE DECISION MADE: 28-JUL-21 Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medical surgical mask Shantou T&K Medical Equipment Fact510(k) NO: K210380(Traditional) ATTN: Wan Li PHONE NO : 86 159 92258456 No.8 Workshop, Wanji South Second SE DECISION MADE: 08-JUL-21 Shantou CN 515065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Blustone Synergy Diamond SA Cervical System Blustone Synergy, LLC 510(k) NO: K210382(Traditional) ATTN: Tom Gentry PHONE NO : 760 9926118 5520 Ventana Ct SE DECISION MADE: 23-JUL-21 Pueblo CO 81005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Magneto Nasal Mask Respironics, Inc. 510(k) NO: K210386(Traditional) ATTN: Anna Danley PHONE NO : 412 5423513 1740 Golden Mile Highway SE DECISION MADE: 12-JUL-21 Monroeville PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single-use medical face mask Zhuhai Herald Datanetics Limited. 510(k) NO: K210391(Traditional) ATTN: Jackson Leung PHONE NO : 0756 892 0609 Building#2, No.1 Pingxi Road 6, NaSE DECISION MADE: 22-JUL-21 Zhuhai CN 519060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Surgical Face Mask Shandong Zhushi Pharmaceutical Gro510(k) NO: K210409(Traditional) ATTN: Junhui Zhu PHONE NO : 86 530 7150111 No.6 Shande Road, Shan County SE DECISION MADE: 28-JUL-21 Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pac-Dent Ceramic Nanohybrid Resin Pac-Dent, Inc. 510(k) NO: K210412(Traditional) ATTN: Jingtian Peng PHONE NO : 909 8390888 111 670 Endeavor Circle SE DECISION MADE: 26-JUL-21 Brea CA 92821 510(k) STATEMENT DEVICE: QSM software, QSMetric Medimagemetric LLC 510(k) NO: K210415(Traditional) ATTN: Yi Wang PHONE NO : 917 7332285 171 Floral Ave SE DECISION MADE: 22-JUL-21 Johnson City NY 13790 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ReCross IMDS Operations B.V. 510(k) NO: K210431(Traditional) ATTN: Edwin Schulting PHONE NO : 315 082 00230 Ceintuurbaan Noord 150 SE DECISION MADE: 15-JUL-21 Roden NL 9301 NZ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SC1 Handheld Ultrasound Imaging System (Model: SC1) FCU Co., Ltd. 510(k) NO: K210468(Traditional) ATTN: Lee Hee Yeon PHONE NO : 82 42 9369078 B-620/621, Biz Center, 17, Techno SE DECISION MADE: 23-JUL-21 Yuseong-gu KR 34013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Insight Agile DRF Imaging Engineering, LLC 510(k) NO: K210469(Traditional) ATTN: George Jachode PHONE NO : 239 2331371 1318 NW 7th Ave SE DECISION MADE: 27-JUL-21 Cape Coral FL 33993 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE AtriCure Inc. 510(k) NO: K210477(Traditional) ATTN: Melissa Smallwood PHONE NO : 513 6444736 7555 Innovation Way SE DECISION MADE: 26-JUL-21 Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AcuPebble SA Acurable Limited 510(k) NO: K210480(Traditional) ATTN: Esther Rodriguez-Villegas PHONE NO : 44 7939 036867____ Finsgate, 5-7 Cranwood Street SE DECISION MADE: 06-JUL-21 London GB EC1V 9EE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InMode RF Pro System InMode MD Ltd. 510(k) NO: K210492(Traditional) ATTN: Amit Goren PHONE NO : 972 4 9097470 Tabor Building, Shaar Yokneam SE DECISION MADE: 12-JUL-21 Yokneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System SeaSpine Orthopedics Corporation 510(k) NO: K210497(Special) ATTN: Aly Alvarez PHONE NO : 619 8844342 5770 Armada Drive SE DECISION MADE: 07-JUL-21 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Mask Changzhou Holymed Products Co., Lt510(k) NO: K210524(Traditional) ATTN: Shan Shang PHONE NO : 86 182 51200602 525 Changwu Road South SE DECISION MADE: 07-JUL-21 Changzhou CN 213167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medtronic Extended infusion set Unomedical A/S 510(k) NO: K210544(Traditional) ATTN: Lone Sylvest Vestergaard JepPHONE NO : 45 6 0775559 Aaholmvej 1-3 SE DECISION MADE: 16-JUL-21 Osted DK 4320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive Pulse System NuVasive, Incorporated 510(k) NO: K210574(Traditional) ATTN: Manthan Damani PHONE NO : 858 4582272 7475 Lusk Boulevard SE DECISION MADE: 29-JUL-21 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medical Nitrile Examination Gloves (Power free, Blue) Jiangxi Hongda Medical Equipment G510(k) NO: K210578(Traditional) ATTN: Yang Qinghua PHONE NO : 86 189 7009359 39 South Shengli RD. Jinxian CountSE DECISION MADE: 10-JUL-21 Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System OTU Medical Inc. 510(k) NO: K210579(Traditional) ATTN: Geping Liu PHONE NO : 408 7977313 2231A Fortune Drive SE DECISION MADE: 22-JUL-21 San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AortaSTAT Occlusion Device RenalPro Medical, Inc. 510(k) NO: K210602(Traditional) ATTN: James Twitchell PHONE NO : 508 397 6191 2370-B Walsh Avenue SE DECISION MADE: 09-JUL-21 Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro Heraeus Medical GmbH 510(k) NO: K210607(Traditional) ATTN: Ljuba Jaeckel PHONE NO : 49 6181 353138 Phillipp-Reis-Str. 8/13 SE DECISION MADE: 09-JUL-21 Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM Free.Max Siemens Medical Solutions USA, Inc510(k) NO: K210611(Traditional) ATTN: Andrew Turner PHONE NO : 610 8505627 40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 01-JUL-21 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Route 92 Medical Full Length 088 Access System Route 92 Medical Inc. 510(k) NO: K210635(Special) ATTN: Kirsten Valley PHONE NO : 650 5811179 155 Bovet Road, Suite 100 SE DECISION MADE: 27-JUL-21 San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE Planner Hip Orthosoft d/b/a Zimmer CAS 510(k) NO: K210653(Traditional) ATTN: Paul Hardy PHONE NO : 574 4536739 75 Queen Street, Suite 3300 SE DECISION MADE: 07-JUL-21 Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) Ra Medical Systems, Inc. 510(k) NO: K210664(Traditional) ATTN: Jami Miller PHONE NO : 760 8041648 2070 Las Palmas Drive SE DECISION MADE: 27-JUL-21 Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Chest-CAD Imagen Technologies, Inc 510(k) NO: K210666(Traditional) ATTN: Robert Lindsey PHONE NO : 917 8304721 151 West 26th Street, Suite 1001 SE DECISION MADE: 20-JUL-21 New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Nitrile Medical Examination Glove Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K210684(Traditional) ATTN: Guo Hua PHONE NO : 86 134 85097856 No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 20-JUL-21 Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Patient Examination Glove Yunnan Huazhiyuan Medical Technolo510(k) NO: K210686(Traditional) ATTN: Yun Gao PHONE NO : 86 182 52909158 Yangjie Industrial Park, Jianshui SE DECISION MADE: 21-JUL-21 Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown O&M Halyard, Inc 510(k) NO: K210688(Abbreviated) ATTN: Kimberly Lewis PHONE NO : 470 4139064 9120 Lockwood Blvd SE DECISION MADE: 21-JUL-21 Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Nitrile Medical Examination Glove Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K210691(Traditional) ATTN: Guo Hua PHONE NO : 86 134 85097856 No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 30-JUL-21 Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HM70 EVO Diagnostic Ultrasound System Samsung Medison CO., LTD. 510(k) NO: K210713(Traditional) ATTN: Jee Young Ju PHONE NO : 82 2 21940861 3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 09-JUL-21 Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bone Screws dia. 5,0 mm LimaCorporate S.p.A. 510(k) NO: K210717(Traditional) ATTN: Antonia Trevisan PHONE NO : Via Nazionale 52 SE DECISION MADE: 12-JUL-21 Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Change Healthcare Anatomical AI Change Healthcare Canada Company 510(k) NO: K210719(Traditional) ATTN: Chester McCoy PHONE NO : 404 3382088 10711 Cambie Road SE DECISION MADE: 20-JUL-21 Richmond CA V6X 3GS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Patient Examination Glove Jiangxi Zhonghong Pulin Medical Pr510(k) NO: K210723(Traditional) ATTN: Zhou Ziyu PHONE NO : 86 199 31401105 Yinshawan Park,High-tech IndustriaSE DECISION MADE: 12-JUL-21 Jiujiang CN 332500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: doctorgram Stethoscope DES-I GV Concepts 510(k) NO: K210736(Traditional) ATTN: Ching-Kay Chow PHONE NO : 408 7813861 3240 S White Rd #286 SE DECISION MADE: 27-JUL-21 San Jose CA 95148 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acumed Clavicle Hook Plating System Acumed LLC 510(k) NO: K210750(Traditional) ATTN: Janki Bhatt PHONE NO : 503 7188753 5885 NE Cornelius Pass Road SE DECISION MADE: 15-JUL-21 Hillsboro OR 97124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Velguard Surgical Face Mask Estee Exports Health Care Division510(k) NO: K210761(Traditional) ATTN: Zachary Wilson PHONE NO : 805 3651348 8/3176 A3 & A4, Jothipuram, 2nd StSE DECISION MADE: 16-JUL-21 Tirupur IN 641602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wrist Blood Pressure Monitor, Blood Pressure Monitor Andon Health Co., Ltd. 510(k) NO: K210768(Abbreviated) ATTN: Liu Yi PHONE NO : 86 22 87611660 9223 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 30-JUL-21 Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor Andon Health Co., Ltd. 510(k) NO: K210770(Abbreviated) ATTN: Liu Yi PHONE NO : 86 22 87611660 9223 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 29-JUL-21 Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Examination Gloves 5R MED Instruments (Chengdu) Co., 510(k) NO: K210776(Traditional) ATTN: Yuzhang Pan PHONE NO : 86 139 28606563 Building 9, Section 1, No.618 of WSE DECISION MADE: 12-JUL-21 Chengdu CN 611130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Us2.v1 eko.ai Pte. Ltd. d/b/a Us2.ai 510(k) NO: K210791(Traditional) ATTN: James Hare PHONE NO : 65 62327857 2 College Road, #02-00 SE DECISION MADE: 27-JUL-21 Singapore SG 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medical PVC Examination Gloves Jiangxi Hongda Medical Equipment G510(k) NO: K210821(Traditional) ATTN: Yang Qinghua PHONE NO : 86 189 70093059 39 South Shengli Road, Jinxian CouSE DECISION MADE: 09-JUL-21 Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Purism Disposable Surgical Mask Chuzhou Daddy's Choice Science and510(k) NO: K210856(Traditional) ATTN: Amie Yang PHONE NO : 86 550 30369811 Middle of Nanjing Road, Langya DisSE DECISION MADE: 28-JUL-21 Chuzhou CN 239000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hemafuse System Sisu Global Health 510(k) NO: K210862(Traditional) ATTN: Gillian Henker PHONE NO : 412 7219269 2720 Sisson Street SE DECISION MADE: 29-JUL-21 Baltimore MD 21211 510(k) STATEMENT DEVICE: MEO Med Disposable Medical Face Mask Fujian MEO Medical Technology Limi510(k) NO: K210870(Traditional) ATTN: Zhuang Yan PHONE NO : 86 135 99192517 Floor 4th, No. 1 Production BuildiSE DECISION MADE: 30-JUL-21 Ningde CN 352100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Evolve System with the T3 Applicator InMode Ltd. 510(k) NO: K210877(Traditional) ATTN: Amit Goren PHONE NO : 972 4 9097470 Tabor Building, Shaar Yokneam SE DECISION MADE: 19-JUL-21 Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1Derful HS, 1Derful HT 1Derful, Inc 510(k) NO: K210884(Traditional) ATTN: Mohamad Alkassab PHONE NO : 346 3319811 38345 Donigan Road SE DECISION MADE: 27-JUL-21 Brookshire TX 77423 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS Multi Unit Abutment System Neobiotech Co., Ltd. 510(k) NO: K210903(Traditional) ATTN: Young-Ku Heo PHONE NO : 82 2 5822885 #204, 36, Digital-ro 27gil, Guro-gSE DECISION MADE: 23-JUL-21 Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Snore Bandit SnoreBandit LLC 510(k) NO: K210910(Traditional) ATTN: Garry Thynne PHONE NO : 702 2833557 8176 Merlewood Ave SE DECISION MADE: 01-JUL-21 Las Vegas NV 89117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PowerDot PD-01MT2 Muscle Stimulator Smartmissimo Technologies Pte Ltd 510(k) NO: K210938(Special) ATTN: Alexey Pisarev PHONE NO : 65 832 16256 #28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 30-JUL-21 Singapore SG 068807 510(k) STATEMENT DEVICE: Ultra SEP Reliance Orthodontic Products, Inc510(k) NO: K210945(Traditional) ATTN: Christine Cook PHONE NO : 800 3234348 1540 W Thorndale Ave SE DECISION MADE: 08-JUL-21 Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART Taylor Spatial Frame Smith & Nephew, Inc. 510(k) NO: K210953(Traditional) ATTN: Thomas Fearnley PHONE NO : 901 3991224 1450 E Brooks Rd SE DECISION MADE: 29-JUL-21 Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENNOVATE Spinal System Aesculap Implant Systems, LLC 510(k) NO: K210963(Traditional) ATTN: Paul Amudala PHONE NO : 610 4170839 3773 Corporate Parkway SE DECISION MADE: 19-JUL-21 Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single-Use Surgical Mask Model FE2311B BYD Precison Manufacturer Co., Ltd510(k) NO: K210970(Traditional) ATTN: Yubo Guan PHONE NO : 86 77589 8888868765 No.3001 Baohe Road, Baolong IndustSE DECISION MADE: 21-JUL-21 Shenzhen CN 518116 510(k) STATEMENT DEVICE: Grappler Suture Anchor System Paragon 28, Inc. 510(k) NO: K211002(Traditional) ATTN: Haylie Hertz PHONE NO : 303 7200017 14445 Grasslands Dr. SE DECISION MADE: 07-JUL-21 Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-TRAXTM Persona Knee Containment Device K1 Medical LLC 510(k) NO: K211007(Traditional) ATTN: Walt Oko PHONE NO : 203 9134161 56 Newton Road SE DECISION MADE: 01-JUL-21 Woodbridge CT 06525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Patient Examination Gloves Huayuan Medical Technology(Shangqi510(k) NO: K211012(Traditional) ATTN: Huamei Wang PHONE NO : 86 13 705111918 In The North Yard of West 1000m RoSE DECISION MADE: 23-JUL-21 Shangqiu CN 476000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Portray Surround Medical Systems 510(k) NO: K211014(Traditional) ATTN: Elizabeth Sullivan PHONE NO : 919 4244904 175 Southport Dr, Suite 900 SE DECISION MADE: 28-JUL-21 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Procedural Ear-loop Face Mask Changzhou DSB Medical Co., LTD 510(k) NO: K211042(Traditional) ATTN: Sunny Han PHONE NO : 86 519 88363800 No. 98 Fumin Rd, Changzhou EconomiSE DECISION MADE: 15-JUL-21 Changzhou CN 213025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Straumann RidgeFit Implants Institut Straumann AG 510(k) NO: K211052(Traditional) ATTN: Viviana Horhoiu PHONE NO : 41 61 9651512 Peter Merian Weg 12 SE DECISION MADE: 08-JUL-21 Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Grosz Play Feel RB Health (US) LLC 510(k) NO: K211088(Traditional) ATTN: Elizabeth Viguerie PHONE NO : 973 4042715 399 Interpace Parkway SE DECISION MADE: 09-JUL-21 Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nerve and Muscle Stimulator Shenzhen XFT Medical Limited 510(k) NO: K211094(Traditional) ATTN: Cindy Peng PHONE NO : 86 755 29888818 Room 203, Building 1, Biomedicine SE DECISION MADE: 08-JUL-21 Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTL-899 FP BTL Industries Inc. 510(k) NO: K211107(Traditional) ATTN: David Chmel PHONE NO : 1 866 2851656 362 Elm Street SE DECISION MADE: 09-JUL-21 Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SureMAX-SA Cervical Standalone System Additive Implants, Inc 510(k) NO: K211111(Traditional) ATTN: Jeff Horn PHONE NO : 602 7958850 3101 E. Shea Blvd, Suite 122 SE DECISION MADE: 16-JUL-21 Phoenix AZ 85028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Zavation Spinal System Zavation Medical Products LLC 510(k) NO: K211113(Traditional) ATTN: Katie Motley PHONE NO : 601 9191119 220 Lakeland Parkway SE DECISION MADE: 12-JUL-21 Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Neocis Guidance System (NGS) with Intraoral Fiducial Array Neocis Inc. 510(k) NO: K211129(Traditional) ATTN: William Tapia PHONE NO : 305 7532742 2800 Biscayne Blvd Suite 600 SE DECISION MADE: 28-JUL-21 Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Nitrile Medical Examination Glove Siyang Threeguard Medical Supplies510(k) NO: K211131(Traditional) ATTN: Guo Hua PHONE NO : 86 134 85097856 East of Nanhai Road and South of GSE DECISION MADE: 29-JUL-21 Suqian CN 223799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Vinyl Patient Examination Gloves Shijiazhuang Hongjun Plastic Manuf510(k) NO: K211177(Traditional) ATTN: Lv Zhanmin PHONE NO : 86 311 66766067 Xinye Industrial Zone, Wangtong ViSE DECISION MADE: 17-JUL-21 Shijiazhuang CN 051330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: xvision Spine system (XVS) Augmedics Ltd 510(k) NO: K211188(Traditional) ATTN: Tami Harel PHONE NO : 972 4 3730111 1 Ha-Tsmikha St SE DECISION MADE: 19-JUL-21 Yokneam Illit IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Grivamax Family of Lasers, Models 272 and 148 Leana Orders, Inc 510(k) NO: K211192(Traditional) ATTN: Leonid Krits PHONE NO : 718 4151901 12 Jefferson Boulevard, Suite 1F SE DECISION MADE: 20-JUL-21 Staten Island NY 10312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs Guangdong Kingfa Sci. & Tech. Co.,510(k) NO: K211220(Traditional) ATTN: Xiaoge Yu PHONE NO : 86 13 570952157 No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 22-JUL-21 Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: qER-Quant Qure.ai Technologies 510(k) NO: K211222(Traditional) ATTN: Pooja Rao PHONE NO : 91 22 68505800 Level 7, Commerz II, InternationalSE DECISION MADE: 30-JUL-21 Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System Boston Scientific Corporation 510(k) NO: K211223(Traditional) ATTN: Rachel Nankervis PHONE NO : 508 6834755 300 Boston Scientific Way SE DECISION MADE: 21-JUL-21 Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIS Ti-base abutment Dentsply Sirona 510(k) NO: K211225(Traditional) ATTN: Rebecca Sporer PHONE NO : 717 8494793 221 West Philadelphia Street, SuitSE DECISION MADE: 28-JUL-21 York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vinyl compound examination gloves Hebei Titans Hongsen Medical Techn510(k) NO: K211229(Traditional) ATTN: Feng Shuangyan PHONE NO : 86 13 733285059 Eastern Industrial Zone SE DECISION MADE: 29-JUL-21 Nangong CN 051800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UltraTemp Rez II Ultradent Products, Inc. 510(k) NO: K211237(Traditional) ATTN: Shawn L. Quigley PHONE NO : 801 9166567 505 W Ultradent Drive (10200 SouthSE DECISION MADE: 13-JUL-21 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vinyl Patient Examination Gloves Jiangxi Shengda Medical Technology510(k) NO: K211239(Traditional) ATTN: Yun Gao PHONE NO : 86 182 52909158 No.25 Factory, Wencheng Block, HigSE DECISION MADE: 17-JUL-21 Shangrao CN 334711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PET VCAR GE Medical Systems SCS 510(k) NO: K211247(Traditional) ATTN: Elizabeth Mathew PHONE NO : 262 424 7774 283, rue de la Miniere SE DECISION MADE: 27-JUL-21 BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Altor Safety 3-Ply Surgical Mask (Model:62222) Altor Safety LLC 510(k) NO: K211249(Traditional) ATTN: Jared Scott PHONE NO : 1 845 4228320 711 Executive Boulevard Suite C SE DECISION MADE: 23-JUL-21 Valley Cottage NY 10989 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Vinyl Nitrile Synthetic Gloves Powder Free Tangshan Hongyun Healthcare Produc510(k) NO: K211262(Traditional) ATTN: Suying Le PHONE NO : 86 139 33365259 South Shenggezhuang Village,PachigSE DECISION MADE: 24-JUL-21 Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Nitrile Examination Gloves Shenzhen Shiqiao Science and Techn510(k) NO: K211264(Traditional) ATTN: Mikki Wan PHONE NO : 86 189 22802487 Unit 2105 ,Tower D, Galaxy World pSE DECISION MADE: 30-JUL-21 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Volpara Imaging Software Volpara Health Technologies Limite510(k) NO: K211279(Special) ATTN: Ralph Highnam PHONE NO : 64 4 4996029 Level 14-15, Simpl House, 40 MerceSE DECISION MADE: 27-JUL-21 Wellington NZ 6011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D Fiagon GmbH 510(k) NO: K211291(Traditional) ATTN: Dirk Mucha PHONE NO : 49 3320 2012124 Neuendorfstr. 23b SE DECISION MADE: 19-JUL-21 Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys Syphilis Roche Diagnostics 510(k) NO: K211302(Traditional) ATTN: Bin Sun PHONE NO : 317 5213107 9115 Hague Road SE DECISION MADE: 20-JUL-21 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCS Lung Solution TransMedics, Inc. 510(k) NO: K211314(Traditional) ATTN: Miriam Provost PHONE NO : 978 4947897 200 Minuteman Road, Suite 302 SE DECISION MADE: 29-JUL-21 Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. 510(k) NO: K211316(Traditional) ATTN: Connor McCarty PHONE NO : 805 7984205 1266 Kifer Road SE DECISION MADE: 23-JUL-21 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRUXVIEW CRUXELL Corp. 510(k) NO: K211317(Traditional) ATTN: Boeun Bang PHONE NO : 82 42 9352554 405, Migun techno World II, 187, TSE DECISION MADE: 29-JUL-21 Daejeon KR 34025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Senhance Surgical System Asensus Surgical, Inc. 510(k) NO: K211325(Traditional) ATTN: Taylor Fisher PHONE NO : 919 7658400 1 TW Alexander Drive, Suite 160 SE DECISION MADE: 27-JUL-21 Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Diode Laser Machine, Model Number: BM-100 Zhengzhou Bestview St Co., Ltd. 510(k) NO: K211335(Traditional) ATTN: Yangchun Jia PHONE NO : 86 158 03801506 Room 204, 20F, Lande Center, HuayaSE DECISION MADE: 28-JUL-21 Zhengzhou CN 450000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Elect510(k) NO: K211337(Traditional) ATTN: Zhang Wei PHONE NO : 86 755 81885655 Keji 12th Road South, Hi-Tech InduSE DECISION MADE: 01-JUL-21 Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBOTRAP III Revascularization Device Neuravi Limited 510(k) NO: K211338(Traditional) ATTN: Niall Fox PHONE NO : 353 86 1730678 Block 3, Ballybrit Business Park SE DECISION MADE: 30-JUL-21 Galway IE H91 K5YD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Blue Nitrile Exam Gloves Jiangxi Surefine Medical Co., Ltd.510(k) NO: K211341(Traditional) ATTN: Steve Zhu PHONE NO : 86 1380 5860705 Jinshan Rd., Yugan Hi-tech IndustrSE DECISION MADE: 29-JUL-21 Shangrao CN 335100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medical Face Mask HuBei Kangning Protective Products510(k) NO: K211363(Traditional) ATTN: Zhao Yuxuan PHONE NO : 86 139 07227068 Special No1, Xuefu Road, Xiantao CSE DECISION MADE: 24-JUL-21 Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.via RT Image Suite Siemens Medical Solutions USA Inc.510(k) NO: K211379(Traditional) ATTN: Clayton Ginn PHONE NO : 865 8982692 810 Innovation Drive SE DECISION MADE: 30-JUL-21 Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elexir Nu Eyne Co., Ltd. 510(k) NO: K211380(Traditional) ATTN: Dong Seong Lee PHONE NO : 82 2 69538120 #608, 28, Digital-ro 30-gil, Guro-SE DECISION MADE: 30-JUL-21 Seoul KR 08389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MySpine WebPlanner & MyBalance Medacta International SA 510(k) NO: K211386(Traditional) ATTN: Stefano Baj PHONE NO : 41 91 6966060 Strada Regina SE DECISION MADE: 23-JUL-21 Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Selethru(TM) NC PTCA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd. 510(k) NO: K211393(Traditional) ATTN: Maggie Xu PHONE NO : 86 150 51476125 F2-3, BLDG 6, No. 8, Jinfeng Road,SE DECISION MADE: 02-JUL-21 Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO-I Einstein Works LLC 510(k) NO: K211395(Traditional) ATTN: Roy Bachrach PHONE NO : 001 713 7236000 5312 Elm St SE DECISION MADE: 28-JUL-21 Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powersculp laser lipolysis system Lotuxs Medtech (Suzhou) Co., Ltd. 510(k) NO: K211402(Traditional) ATTN: Na Wu PHONE NO : 86 0512 62880553 RM301, NW-06, Nanopolis Suzhou, 99SE DECISION MADE: 30-JUL-21 Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Penumbra System (RED 68 Reperfusion Catheter) Penumbra, Inc. 510(k) NO: K211411(Traditional) ATTN: Micaela Victoria PHONE NO : 510 9902082 One Penumbra Place SE DECISION MADE: 01-JUL-21 Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Jiangsu Medplus Non-woven Manufact510(k) NO: K211422(Traditional) ATTN: Shuying An PHONE NO : 86 527 80300123 No.217 East Wencheng Road, EconomiSE DECISION MADE: 02-JUL-21 Siyang CN 223700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StealthStation Spinous Process Clamps Medtronic Navigation 510(k) NO: K211442(Traditional) ATTN: Victoria Baldock PHONE NO : 423 8635907 826 Coal Creek Circle SE DECISION MADE: 08-JUL-21 Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors Shen Wei USA Inc. 510(k) NO: K211455(Traditional) ATTN: Cheryl Reep PHONE NO : 510 4298692 33278 Central Ave Ste 102 SE DECISION MADE: 28-JUL-21 Union City CA 94587 510(k) STATEMENT DEVICE: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform Edwards Lfesciences 510(k) NO: K211465(Traditional) ATTN: Chirag Shah PHONE NO : 949 2501580 One Edwards Way SE DECISION MADE: 08-JUL-21 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NubeX TechHeim Co., Ltd 510(k) NO: K211480(Traditional) ATTN: Weon Yong Lee PHONE NO : 82 2 20280733 Floor 3.4, 21, Banpo-daero 24-gil SE DECISION MADE: 08-JUL-21 Seoul KR 06648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dental Impression Material Nanchang Dental Bright Technology 510(k) NO: K211489(Traditional) ATTN: Justin Qin PHONE NO : 86 15 079010001 Building 182, Jiahai Industrial PaSE DECISION MADE: 28-JUL-21 Nanchang CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RadiForce RX370 EIZO Corporation 510(k) NO: K211491(Abbreviated) ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468 153 Shimokashiwano SE DECISION MADE: 12-JUL-21 Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pounce Thrombectomy System Surmodics, Inc. 510(k) NO: K211492(Traditional) ATTN: Holly Ramirez PHONE NO : 952 5007545 9924 W 74th Street SE DECISION MADE: 30-JUL-21 Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Monarch Platform Auris Health, Inc. 510(k) NO: K211493(Special) ATTN: Shikha Gola PHONE NO : 201 2403891 150 Shoreline Drive SE DECISION MADE: 09-JUL-21 Redwood CA 94065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOS PMP Sorin Group Italia S.R.L 510(k) NO: K211495(Special) ATTN: Luigi Vecchi PHONE NO : 39 0535 29957 Via Statale 12 Nord. 86 SE DECISION MADE: 12-JUL-21 Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Mask Honeywell Safety Products 510(k) NO: K211497(Traditional) ATTN: Ivy Pettis PHONE NO : 401 8640496 10 Thurber Boulevard SE DECISION MADE: 28-JUL-21 Smithfield RI 02917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PowerLook Density Assessment V4.0 iCAD, Inc. 510(k) NO: K211506(Traditional) ATTN: Heather Reed PHONE NO : 603 3091945 98 Spit Brook Rd Suite 100 SE DECISION MADE: 12-JUL-21 Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: decimal Bolus .decimal, LLC 510(k) NO: K211511(Traditional) ATTN: Kevin Erhart PHONE NO : 407 3303300 121 Central Park Place SE DECISION MADE: 01-JUL-21 Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Longeviti PorousFit implant Longeviti Neuro Solutions, LLC 510(k) NO: K211514(Traditional) ATTN: Heather Hourihan PHONE NO : 410 5271803 303 International Circle Suite 190SE DECISION MADE: 15-JUL-21 Hunt Valley MD 21030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SwiftNINJA Steerable Microcatheter Merit Medical Systems, Inc. 510(k) NO: K211525(Traditional) ATTN: Luke Meidell PHONE NO : 801 2084623 1600 West Merit Parkway SE DECISION MADE: 16-JUL-21 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMO S A.T.S. Applicazione Tecnologie Spe510(k) NO: K211542(Traditional) ATTN: Livia Pillitteri PHONE NO : 39 035 584311 Via Alessandro Volta, 10 SE DECISION MADE: 09-JUL-21 Torre De Roveri IT 24060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Edma Group, LLC 510(k) NO: K211547(Traditional) ATTN: Vio Cretu PHONE NO : 3634 E Piccadilly Rd SE DECISION MADE: 15-JUL-21 Phoenix AZ 85018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARSTEM Calcar Reamer Guide Smith & Nephew, Inc. 510(k) NO: K211548(Traditional) ATTN: Pamela Hopkins PHONE NO : 901 4277303 1450 East Brooks Rd SE DECISION MADE: 19-JUL-21 Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Extreme X8 Magic Mobility 510(k) NO: K211574(Traditional) ATTN: Alex Suen PHONE NO : 61 3 87915600 3 International Court SE DECISION MADE: 09-JUL-21 Scoreby AU 3179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avanti Orthopaedics Ulnar Shortening System Avanti Orthopaedics, Inc. 510(k) NO: K211592(Traditional) ATTN: J. Doug Patterson PHONE NO : 302 5306369 4606 Simon Road SE DECISION MADE: 16-JUL-21 Wilmington DE 19803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Klassic Knee System Total Joint Orthopedics, Inc. 510(k) NO: K211602(Traditional) ATTN: Chris Weaber PHONE NO : 801 4866070 1567 E. Stratford Avenue SE DECISION MADE: 23-JUL-21 Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation 510(k) NO: K211633(Traditional) ATTN: Janine F. Reyes PHONE NO : 714 6697853 1385 Shimoshigami SE DECISION MADE: 22-JUL-21 Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vision Monitor - MonpackONE Metrovision 510(k) NO: K211643(Traditional) ATTN: Jacques Charlier PHONE NO : 33 3201 71956 4 rue des Platanes SE DECISION MADE: 26-JUL-21 Perenchies FR 59840 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINE Osteotomy Bodycad Laboratories, Inc. 510(k) NO: K211646(Traditional) ATTN: Nadine Adia PHONE NO : 418 5271388 2035, rue du Haut-Bord SE DECISION MADE: 28-JUL-21 Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: aPROMISE EXINI Diagnostics AB 510(k) NO: K211655(Traditional) ATTN: Aseem Anand PHONE NO : 46 706 604084 Ideon Science Park, Scheelevägen 2SE DECISION MADE: 27-JUL-21 Lund SE SE-223 70 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Zap-X Radiosurgical System Zap Surgical Systems, Inc. 510(k) NO: K211663(Traditional) ATTN: Jim Talbot PHONE NO : 650 7938250 590 Taylor Way SE DECISION MADE: 29-JUL-21 San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMK Sphere Revision Medacta International S.A. 510(k) NO: K211664(Traditional) ATTN: Stefano Baj PHONE NO : 41 91 6966060 Strada Regina SE DECISION MADE: 29-JUL-21 Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEOS Limb Salvage System Onkos Surgical 510(k) NO: K211677(Traditional) ATTN: Matthew (Matt) Vernak PHONE NO : 551 5791081 77 East Halsey Rd SE DECISION MADE: 28-JUL-21 Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-Air and Athlos-1 and Athlos-Air Athlos Oy 510(k) NO: K211688(Third Party - Traditional) ATTN: Konstantinos Spartiotis PHONE NO : 358 401 362566 Klovinpellontie 1-3, Tower 2 SE DECISION MADE: 22-JUL-21 Espoo FI 02180 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System Orthofix Inc. 510(k) NO: K211710(Traditional) ATTN: Jacki Koch PHONE NO : 214 9372100 3451 Plano Parkway SE DECISION MADE: 30-JUL-21 Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UltraLase Flexible CO2 Laser Waveguide W & R Investments, LLC dba Laser E510(k) NO: K211761(Special) ATTN: Robert I Rudko PHONE NO : 508 5202552 113 Cedar Street, SuiteS5 SE DECISION MADE: 30-JUL-21 Milford MA 10757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 ControlRad, Inc 510(k) NO: K211782(Special) ATTN: Chris Fair PHONE NO : 275 Scientific Drive NW #1100 SE DECISION MADE: 01-JUL-21 Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HALO Nico.Lab B.V. 510(k) NO: K211788(Special) ATTN: Merel Boers PHONE NO : 31 20 2440852 Paasheuvelweg 25 SE DECISION MADE: 08-JUL-21 Amsterdam NL 1105 BP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D Imaging Package with XD Detectors Agfa N.V. 510(k) NO: K211790(Traditional) ATTN: Wim Govaerts PHONE NO : 32 3444 6246 Septestraat 27 SE DECISION MADE: 30-JUL-21 Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StitchKit Origami Surgical Inc . 510(k) NO: K211792(Special) ATTN: John Gillespie PHONE NO : 774 5670277 42 Main St. SE DECISION MADE: 16-JUL-21 Madison NJ 07940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System Hyperfine, Inc. 510(k) NO: K211818(Special) ATTN: Christine Kupchick PHONE NO : 203 3433404 530 Old Whitfield Street SE DECISION MADE: 07-JUL-21 Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEKA Motus AZ El.En Electronic Engineering SPA 510(k) NO: K211821(Special) ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807 Via Baldanzese 17 SE DECISION MADE: 06-JUL-21 Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Electrode Market Disposable Surface Electrodes Electrode Market Co.,Ltd. 510(k) NO: K211839(Traditional) ATTN: Seolmin Jeong PHONE NO : 82 10 20226445 205, Manhae-ro, Danwon-gu, A-dong SE DECISION MADE: 28-JUL-21 Ansan-Si KR 15421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc510(k) NO: K211859(Third Party - Traditional) ATTN: Sulgue Choi PHONE NO : 425 2819898 22010 South East 51st Street SE DECISION MADE: 20-JUL-21 Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TAIJI Professional Series Level 3 Surgical Face Mask Taiji Medical Supplies, Inc. 510(k) NO: K211861(Third Party - Abbreviated) ATTN: Katherine Giannamore PHONE NO : 305 5079843 3211 Progress Drive SE DECISION MADE: 28-JUL-21 Lincolnton NC 28092 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Bencox THR System Corentec Co., Ltd. 510(k) NO: K211866(Special) ATTN: Seungri Kim PHONE NO : 82 41 4107117 12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 14-JUL-21 Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS 510(k) NO: K211874(Special) ATTN: Mie Dyrholm PHONE NO : 45 56 868492 Sandet 6 SE DECISION MADE: 28-JUL-21 Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS 510(k) NO: K211875(Special) ATTN: Mie Dyrholm PHONE NO : 45 56 868492 Sandet 6 SE DECISION MADE: 28-JUL-21 Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MolecuLightDX MolecuLight Inc. 510(k) NO: K211901(Special) ATTN: Jordan John PHONE NO : 416 5425522 Suite 700, 425 University Avenue SE DECISION MADE: 21-JUL-21 Toronto CA M5G 1T6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vital Signs Oxehealth Limited 510(k) NO: K211906(Special) ATTN: Hugh Lloyd-Jukes PHONE NO : 44 186 5900599 Magdalen Centre North, The Oxford SE DECISION MADE: 20-JUL-21 Oxford GB OX4 4GA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-6 Atrioseptostomy Catheter NuMED, Inc. 510(k) NO: K211910(Special) ATTN: Nichelle LaFlesh PHONE NO : 315 3284491 2880 Main Street SE DECISION MADE: 19-JUL-21 Hopkinton NY 12965 510(k) STATEMENT DEVICE: Fixxsure Anterior Lumbar Plate and Screw System Oak Tree Engineering, LLC. 510(k) NO: K211932(Traditional) ATTN: Douglas W Neary PHONE NO : 805 7973003 419 Main Street, #242 SE DECISION MADE: 27-JUL-21 Huntington Beach CA 92648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EleVation Breast Biopsy System Bard Peripheral Vascular 510(k) NO: K211933(Special) ATTN: Meghan McKelvey PHONE NO : 602 8305063 1625 W. 3rd Street SE DECISION MADE: 15-JUL-21 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Physica LMC Knee System LimaCorporate 510(k) NO: K211938(Special) ATTN: Roberto Gabetta PHONE NO : 39 338 6439379 Via Nazionale, 52 SE DECISION MADE: 13-JUL-21 Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ExacTrac Dynamic Brainlab AG 510(k) NO: K211939(Special) ATTN: Chiara Cunico PHONE NO : 49 89 9915680 Olof-Palme-Str. 9 SE DECISION MADE: 22-JUL-21 Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medline UNITE® Digital Fusion Screw System Medline Industries, Inc. 510(k) NO: K211944(Special) ATTN: Jennifer Mason PHONE NO : 847 6433652 Three L akes Drive SE DECISION MADE: 22-JUL-21 Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Soniquence Reusable Bipolar Cable Soniquence, LLC 510(k) NO: K211946(Special) ATTN: Suzanne Lucas PHONE NO : 516 6341370 2477 Grand Avenue SE DECISION MADE: 16-JUL-21 Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GI Genius Cosmo Artificial Intelligence - AI510(k) NO: K211951(Special) ATTN: Nhan Ngo Dinh PHONE NO : 39 06 90287198 Riverside II, Sir John Rogerson’s SE DECISION MADE: 23-JUL-21 Dublin IE D02 KV60 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc. 510(k) NO: K211958(Special) ATTN: Kelly McDonnell PHONE NO : 651 2699806 1800 Pyramid Place SE DECISION MADE: 21-JUL-21 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO+ Adult WaisMed Ltd 510(k) NO: K211968(Special) ATTN: Shifra Hoch PHONE NO : 972 9 9517444 10 Amal St. Afek Industrial Park SE DECISION MADE: 22-JUL-21 Rosh Ha'Ayin IL 4809234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASC Surgical Mask Mid-America Safety Corp. 510(k) NO: K211984(Third Party - Traditional) ATTN: Yunxiang (Phil) Fan PHONE NO : 847 9798606 800 Greenleaf Avenue SE DECISION MADE: 25-JUL-21 Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Aveir Introducer Abbott Medical 510(k) NO: K211989(Special) ATTN: Bijal Jain PHONE NO : 1 818 2825438 15900 Valley View Court SE DECISION MADE: 27-JUL-21 Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rist 071 Radial Access Guide Catheter Micro Therapeutics, Inc., d/b/a ev510(k) NO: K211990(Special) ATTN: Amnon Talmor PHONE NO : 352 5142339 9775 Toledo Way SE DECISION MADE: 27-JUL-21 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Catalyst R1 Reverse Shoulder System Catalyst OrthoScience, Inc. 510(k) NO: K211991(Special) ATTN: Dale Davison PHONE NO : 239 3259976 102 14710 Tamiami Trail North SE DECISION MADE: 28-JUL-21 Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Braun Silk.expert Mini CyDen Limited 510(k) NO: K211994(Special) ATTN: Adam Stephens PHONE NO : 44 0 1792274009 Block A, Bay Studios Business ParkSE DECISION MADE: 28-JUL-21 Swansea GB SA1 8QB 510(k) STATEMENT DEVICE: Reveal LINQ Insertable Cardiac Monitor Medtronic. Inc. 510(k) NO: K212008(Special) ATTN: Andrea Artman PHONE NO : 419 7084172 8200 Coral Sea Street NE SE DECISION MADE: 22-JUL-21 Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flex-Thread™ Distal Fibula lntramedullary Nail System Flower Orthopedics Corporation DBA510(k) NO: K212030(Special) ATTN: Amanda Pentecost PHONE NO : 100 Witmer Road SE DECISION MADE: 23-JUL-21 Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FibroScan 230 Echosens 510(k) NO: K212035(Special) ATTN: Karine Bonenfant PHONE NO : 33 1 44827856 6 rue Ferrus SE DECISION MADE: 30-JUL-21 Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HMB32 Dialysis Solution Haemopharm Biofluids S.r.l. 510(k) NO: K212052(Special) ATTN: Francesca Curti PHONE NO : 39 0342 771019 Via dell'Industria 6 SE DECISION MADE: 23-JUL-21 Tovo di S. Agata IT 23030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClariCT.AI ClariPi Inc. 510(k) NO: K212074(Special) ATTN: Hyun-Sook Park PHONE NO : 82 8 7413014 3F, 70-15, Ihwajang-gil SE DECISION MADE: 27-JUL-21 Seoul KR 03088 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 294 TOTAL WITH SUMMARIES 275 TOTAL WITH STATEMENTS 19