510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2022 DEVICE: ROTEM sigma Thromboelastometry System Tem Innovations GmbH 510(k) NO: K201440(Traditional) ATTN: David Jacob PHONE NO : 49 89 45429523 Martin-Kollar-Strasse 15 SE DECISION MADE: 08-JUL-22 Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DiviTum TKa Biovica International AB 510(k) NO: K202852(Traditional) ATTN: Wing Cheng PHONE NO : 46 073 1259245 Dag Hammarskjölds väg 54B SE DECISION MADE: 29-JUL-22 Uppsala SE 75237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGNES Agnes Medical CO., LTD 510(k) NO: K203013(Traditional) ATTN: Chul Lee PHONE NO : 82 31 80209702 (Seohyeon-Dong, 5fCocoplaza), 20, SE DECISION MADE: 14-JUL-22 Seongnam-Si KR 13591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hanger Cranial Band 3D Symbion Logistics, LLC 510(k) NO: K203134(Traditional) ATTN: Roselle Abad PHONE NO : 480 8941755 1119 W Geneva Dr SE DECISION MADE: 01-JUL-22 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Veuron-Brain-mN1 Heuron Co., Ltd. 510(k) NO: K203279(Traditional) ATTN: Dong Hoon Shin PHONE NO : 82 32 4298508 10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 12-JUL-22 Incheon KR 21558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioFire JI Control Panel M420 Maine Molecular Quality Controls, 510(k) NO: K203680(Traditional) ATTN: Joan Gordon PHONE NO : 207 8851072 23 Mill Brook Road SE DECISION MADE: 22-JUL-22 Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Minuteful - kidney test Healthy.io Ltd. 510(k) NO: K210069(Traditional) ATTN: Ron Zohar PHONE NO : 972 54 4454514 2 Ibn Gabirol St. SE DECISION MADE: 06-JUL-22 Tel Aviv IL 6407702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLS Martin IPS Preprosthetic KLS-Martin L.P. 510(k) NO: K210228(Traditional) ATTN: Jennifer Damato PHONE NO : 904 6417746 8005 11201 Saint Johns Industrial ParkwSE DECISION MADE: 08-JUL-22 Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNUCONE Bone Level Implant System SNUCONE Co., LTD. 510(k) NO: K210354(Traditional) ATTN: Ji Eun Song PHONE NO : 82 53 5927525 5, Seongseo-ro 75-gil SE DECISION MADE: 13-JUL-22 Dalseo-gu KR 42703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nerve Tape BioCircuit Technologies, Incorpora510(k) NO: K210665(Traditional) ATTN: Jack Griffis PHONE NO : 404 5836889 1819 Peachtree Road NE, STE 205 SE DECISION MADE: 15-JUL-22 Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLS Martin Individual Patient Solutions KLS-Martin L.P. 510(k) NO: K210731(Traditional) ATTN: Jennifer Damato PHONE NO : 800 6251557 11201 Saint Johns Industrial PKWY SE DECISION MADE: 18-JUL-22 Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS NEPHROCHECK bioMérieux SA 510(k) NO: K210793(Traditional) ATTN: Julien Thao My PHONE NO : 33 4 78877064 376 Chemin de l’Orme SE DECISION MADE: 08-JUL-22 Marcy l’Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DeepRhythmAI Medicalgorithmics S.A. 510(k) NO: K210822(Traditional) ATTN: Marek Dziubinski PHONE NO : 48 22 8251249 Aleje Jerozolimskie 81 SE DECISION MADE: 27-JUL-22 Warsaw PL 02-001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EliA Ro52, EliA Ro60 Phadia AB 510(k) NO: K210902(Traditional) ATTN: Sheryl Skinner PHONE NO : 46 18 165000 Rapsgatan 7P SE DECISION MADE: 27-JUL-22 Uppsala SE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle Becton, Dickinson and Company 510(k) NO: K211085(Traditional) ATTN: Shan Lu PHONE NO : 801 2304317 1 Becton Drive SE DECISION MADE: 01-JUL-22 Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dental diode laser, SOGA Laser, ILaser II Shenzhen Soga Technology Co., Ltd.510(k) NO: K211150(Abbreviated) ATTN: Tse Adrian PHONE NO : 086 159 15873605 D906, Yinxing Technology Building SE DECISION MADE: 01-JUL-22 Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Smith & Nephew Hip Systems Smith & Nephew, Inc. 510(k) NO: K211176(Traditional) ATTN: Crystal Higgenbottom-ShaffePHONE NO : 901 2811627 1450 East Brooks Rd SE DECISION MADE: 01-JUL-22 Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE 400 Carl Zeiss Meditec AG 510(k) NO: K211346(Traditional) ATTN: Hans-Joachim Miesner PHONE NO : 49 364 1220362 Goeschwitzer Strasse 51-52 SE DECISION MADE: 22-JUL-22 Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tablo Hemodialysis System Outset Medical, Inc. 510(k) NO: K211370(Traditional) ATTN: Jennifer Mascioli-Tudor PHONE NO : 669 2318200 3052 Orchard Drive SE DECISION MADE: 29-JUL-22 San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KeriFlex® MCP and PIP Finger Joint Prostheses Keri Medical SA 510(k) NO: K211385(Traditional) ATTN: Bernard Prandi PHONE NO : 41 58 2550130 Route des Acacias, 45a SE DECISION MADE: 27-JUL-22 Geneva CH CH-1227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown Barco Tekstil Sanayi ve Ticaret A.510(k) NO: K211399(Traditional) ATTN: Emre Gomruk PHONE NO : 90 850 3037441 Muratbey Mahallesi Karatoprak CaddSE DECISION MADE: 22-JUL-22 Istanbul TR TR 34540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TransLoc 3D Foundation Fusion Solutions, LLC (510(k) NO: K211496(Traditional) ATTN: Robert Compton PHONE NO : 888 7438736 11916 S. Oxford Ave., Suite 206 SE DECISION MADE: 27-JUL-22 Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wei Nasal Jet Tube Well Lead Medical Co., LTD. 510(k) NO: K211543(Traditional) ATTN: Caroline Gong PHONE NO : 86 20 84758878 C-4 Jinhu Industrial Estate HualonSE DECISION MADE: 21-JUL-22 Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bodyport Cardiac Scale Bodyport Inc. 510(k) NO: K211585(Third Party - Traditional) ATTN: Mara Korsunsky PHONE NO : 650 2001557 970 Folsom Street SE DECISION MADE: 29-JUL-22 San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Planmed Clarity 2D, Planmed Clarify S Planmed Oy 510(k) NO: K211720(Traditional) ATTN: Niina Vuorikallas PHONE NO : 35 820 7795500 Sorvaajankatu 7 SE DECISION MADE: 18-JUL-22 Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DM Converter - TiN coated Medacta International S.A. 510(k) NO: K211891(Traditional) ATTN: Stefano Baj PHONE NO : 41 91 6966060 Strada Regina SE DECISION MADE: 22-JUL-22 Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTI Interna Narrow/Plus Dental Implant System UnicCa B.T.I. Biotechnology Institute, SL510(k) NO: K211952(Traditional) ATTN: Jose Ramon Rivero PHONE NO : 0034 945 297030 Leonardo Da Vinci 14, Parque TecnoSE DECISION MADE: 21-JUL-22 Minano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Alma Diode Tabletop Laser Alma Lasers, Ltd. 510(k) NO: K212073(Traditional) ATTN: Avi Hirshnzon PHONE NO : 972 54 3303402 18 Haharash Street, North IndustriSE DECISION MADE: 14-JUL-22 Caesarea IL 3079895 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MagXtract Collection Tube MagBio Genomics, Inc. 510(k) NO: K212113(Traditional) ATTN: Mothomang Mlalazi-Oyinloye PHONE NO : 301 3020144 944 Clopper Rd SE DECISION MADE: 28-JUL-22 Gaithersburg MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Root Apex Locator Foshan COXO Medical Instrument Co.510(k) NO: K212178(Traditional) ATTN: Yongjian Zheng PHONE NO : 86 137 02544788 BLDG 4, District A, Guangdong New SE DECISION MADE: 20-JUL-22 Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tiche PTA Balloon Dilatation Catheter BrosMed Medical Co., Ltd. 510(k) NO: K212215(Traditional) ATTN: Crystal Lee PHONE NO : 86 769 22892018 2nd and 15th Buildings, SMEs VentuSE DECISION MADE: 19-JUL-22 Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gastric Lightguide (GLG) Naser Dib Gabinet Lekarksi Nasmed 510(k) NO: K212407(Traditional) ATTN: Naser Dib PHONE NO : 48 721 000112 Ul Jana Nowaka Jezioranskiego 7/18SE DECISION MADE: 26-JUL-22 Warszawa PL 03-984 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AgeJet Triworks Group SRL 510(k) NO: K212472(Traditional) ATTN: Elio Piero Berchicci PHONE NO : 0039 0874 1896435 Via Don Giuseppe Mucciardi, 5 SE DECISION MADE: 07-JUL-22 Campochiaro IT 86020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSIX Breeze Datum Dental Ltd. 510(k) NO: K212509(Traditional) ATTN: Arie Goldlust PHONE NO : 972 8 6705400 1 Bat Sheva St., PO Box 6170 SE DECISION MADE: 18-JUL-22 Lod IL 7116003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ultrasonic Scalpel System Surgnova Healthcare Technologies (510(k) NO: K212614(Traditional) ATTN: Guofang Ma PHONE NO : 86 10 64116115 No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 18-JUL-22 Cixi CN 315301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Adin Short Implants Adin Dental Implants Systems Ltd. 510(k) NO: K212775(Traditional) ATTN: Iris Yadin-Herling PHONE NO : 972 4 6426732 Alon Tavor Industrial Zone, P.O. BSE DECISION MADE: 08-JUL-22 Afula IL 1811101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) Abbott Molecular, Inc. 510(k) NO: K212778(Traditional) ATTN: Gina Sammarco PHONE NO : 224 3617627 1300 E. Touhy Ave SE DECISION MADE: 15-JUL-22 Des Plaines IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ProstatID ScanMed, LLC 510(k) NO: K212783(Traditional) ATTN: Randall Jones PHONE NO : 402 9342650 9840 S 140 Street, Suite #8 SE DECISION MADE: 08-JUL-22 Omaha NE 68138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: My3D® Personalized Pelvic Reconstruction Onkos Surgical 510(k) NO: K212815(Traditional) ATTN: Matthew Vernak PHONE NO : 551 5791081 77 East Halsey Rd. SE DECISION MADE: 06-JUL-22 Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Biopsy Refill Needle Suzhou Leapmed Healthcare Corporat510(k) NO: K212819(Traditional) ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043 Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22 Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Semi Automatic Biopsy Instrument Suzhou Leapmed Healthcare Corporat510(k) NO: K212820(Traditional) ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043 Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22 Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Coaxial Biopsy Needle Suzhou Leapmed Healthcare Corporat510(k) NO: K212822(Traditional) ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043 Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22 Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ers2 - ergoline Rehabilitation System ergoline GmbH 510(k) NO: K212883(Traditional) ATTN: Alexandra Lertz PHONE NO : 49 7431 9894138 Lindenstrasse 5 SE DECISION MADE: 15-JUL-22 Bitz DE 72475 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MedWand MedWand Solutions, Inc. 510(k) NO: K212975(Traditional) ATTN: Robert Rose PHONE NO : 844 6339263 23162 Arroyo Vista SE DECISION MADE: 22-JUL-22 Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medispine - Spinal Needle, Glospine - Spinal Needle Global Medikit Limited 510(k) NO: K212982(Traditional) ATTN: Karun Narang PHONE NO : 91 112 7667889 Khasra No 323 MI, Camp Road, SelaqSE DECISION MADE: 29-JUL-22 Dehradun IN 248197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cerebra Sleep System Cerebra Medical Ltd. 510(k) NO: K213007(Traditional) ATTN: Sharon Cholowsky PHONE NO : 1 431 8010332___ 1470 Wilson Place Unit B SE DECISION MADE: 06-JUL-22 Winnipeg CA R3T2N9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment 510(k) NO: K213009(Traditional) ATTN: Zhenhua Xiao PHONE NO : 86 755 86210116 18F, Building B, High-tech park, GSE DECISION MADE: 08-JUL-22 Shenzhen CN 518107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED Facial Mask Shenzhen OSTO Technology Company L510(k) NO: K213056(Traditional) ATTN: Li Yang PHONE NO : 86 755 29769546 No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 07-JUL-22 Shenzhen CN 518100 510(k) STATEMENT DEVICE: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K213060(Traditional) ATTN: Sally He PHONE NO : 86 25 58646395 No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 20-JUL-22 Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Auxilock Titanium Screw-In Suture Anchor Auxein Medical Private Limited 510(k) NO: K213104(Traditional) ATTN: Rahul Luthra PHONE NO : 91 971 7586969 Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 29-JUL-22 Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hemoclip Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K213143(Traditional) ATTN: Yanping Fu PHONE NO : 86 571 87671223 Building 5, Building 6, No. 597 KaSE DECISION MADE: 12-JUL-22 Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Syringe with permanently attached needle, Safety Syringe with permanently attached needle Berpu Medical Technology Co., Ltd.510(k) NO: K213158(Traditional) ATTN: David Yu PHONE NO : 86 188 68131179 No. 14 Xingji Road, Yongxing StreeSE DECISION MADE: 21-JUL-22 Wenzhou CN 325000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NovaCore Semi-Automatic Biopsy Instrument Argon Medical Devices 510(k) NO: K213232(Traditional) ATTN: Daniel Lanois PHONE NO : 469 7311413 1445 Flat Creek Road SE DECISION MADE: 01-JUL-22 Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dornier Thulio DornierMedTech America, Inc 510(k) NO: K213252(Traditional) ATTN: John Hoffer PHONE NO : 770 5146163 1155 Roberts blvd, Suite 100 SE DECISION MADE: 27-JUL-22 Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSLEAD Peripheral Guide Wire Asahi Intecc Co., LTD. 510(k) NO: K213315(Traditional) ATTN: Tomoya Eguchi PHONE NO : 81 561 561859 3-100 Akatsuki-Cho SE DECISION MADE: 01-JUL-22 Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor Verily Life Sciences LLC 510(k) NO: K213357(Traditional) ATTN: Dinesh Puppala PHONE NO : 650 2671263 269 East Grand Avenue SE DECISION MADE: 19-JUL-22 South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SleepCheckRx ResApp Health 510(k) NO: K213360(Traditional) ATTN: Neroli Anderson PHONE NO : 61 416 220239 Level 12, 100 Creek Street SE DECISION MADE: 05-JUL-22 Brisbane AU 4000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM Obsidio, Inc. 510(k) NO: K213385(Traditional) ATTN: Ehsan Jabbarzadeh PHONE NO : 267 2355951 1520 Main Street, Unit 4-C SE DECISION MADE: 01-JUL-22 Columbia SC 29201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AltiVate® Anatomic Shoulder AG e+™ with Markers Encore Medical, L.P. 510(k) NO: K213387(Traditional) ATTN: Michael Siano PHONE NO : 737 2074857 9800 Metric Boulevard SE DECISION MADE: 07-JUL-22 Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINE ALNU (Model: Mine 2.1) HDT Co., Ltd 510(k) NO: K213405(Traditional) ATTN: Sung Hee Chun PHONE NO : 82 624 537752 # 202-ho, 29, Uchi-ro 880beon-gil,SE DECISION MADE: 10-JUL-22 Gwangju KR 61042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS System (Zio Watch) iRhythm Technologies, Inc. 510(k) NO: K213409(Traditional) ATTN: Vishal Kanani PHONE NO : 213 4000963 699 8th Street, Suite 600 SE DECISION MADE: 19-JUL-22 San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGIC Flow-Dependent Microcatheter Balt USA, LLC 510(k) NO: K213435(Traditional) ATTN: Ryan Kenney PHONE NO : 949 7881443 29 Parker SE DECISION MADE: 19-JUL-22 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bladder Scanner, Model Name:M5 Suzhou Peaksonic Medical Technolog510(k) NO: K213488(Traditional) ATTN: Calvin Ma PHONE NO : 86 512 36693388 2A, West Side of Building G4, KunsSE DECISION MADE: 01-JUL-22 Suzhou CN 215341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELNAC Meshed Bilayer Wound Matrix Gunze Limited 510(k) NO: K213498(Traditional) ATTN: Hidenori Nishioka PHONE NO : 81 773 428035 46 Natsumegaichi, Aono SE DECISION MADE: 14-JUL-22 Ayabe, Kyoto JP 623-8513 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AquaA Fresenius Medical Care Rental Ther510(k) NO: K213507(Traditional) ATTN: Denise Oppermann PHONE NO : 781 9969103 920 Winter Street SE DECISION MADE: 27-JUL-22 Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nihon Kohden NKV-330 Ventilator System Nihon Kohden OrangeMed, Inc. 510(k) NO: K213521(Traditional) ATTN: Jacqueline Villanueva PHONE NO : 949 5026448 7045 1800 E. Wilshire Avenue SE DECISION MADE: 01-JUL-22 Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) Grand Work Plastic Products Co., L510(k) NO: K213574(Traditional) ATTN: Wu Yuli PHONE NO : 86 311 66766067 Donggao Industrial Zone, Zanhuang SE DECISION MADE: 12-JUL-22 Shijiazhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tatum Surgical Dental Implant System Suncoast Dental, Inc. dba Tatum Su510(k) NO: K213576(Traditional) ATTN: Tony Fiorello PHONE NO : 1 727 5364880 4500 140th Avenue North Suite 112 SE DECISION MADE: 15-JUL-22 Clearwater FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABMD Software HeartLung Corporation 510(k) NO: K213760(Traditional) ATTN: Morteza Naghavi PHONE NO : 650 4488089 1124 W Carson St SE DECISION MADE: 29-JUL-22 Torrance CA 90502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Joule diVa System Sciton, Inc 510(k) NO: K213761(Traditional) ATTN: Jay M Patel PHONE NO : 650 5438348 925 Commercial Street SE DECISION MADE: 19-JUL-22 Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Insufflation Retention Device Bpendo, LLC 510(k) NO: K213773(Traditional) ATTN: Robert Holbrook PHONE NO : 405 9740776 216 Foreman Circle SE DECISION MADE: 21-JUL-22 Norman OK 73069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single-Use Video Bronchoscopes, Digital Controller Micro-Tech (Nanjing) Co., Lts 510(k) NO: K213782(Traditional) ATTN: Sally He PHONE NO : 86 25 58646395 No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22 Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N Series Patient Monitors Shenzhen Mindray Bio-medical Elect510(k) NO: K213799(Traditional) ATTN: Li Lei PHONE NO : 86 755 81885953 Mindray Building, Keji 12th Road SSE DECISION MADE: 12-JUL-22 Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DuraFuse Clip and Applier System NeuraMedica Inc 510(k) NO: K213813(Traditional) ATTN: Rachel Dreilinger PHONE NO : 503 9140723 402 Beavercreek Road, Suite 110 SE DECISION MADE: 22-JUL-22 Oregon City OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. 510(k) NO: K213822(Special) ATTN: Kaitlyn Hameister PHONE NO : 925 3680589 4300 Hacienda Drive SE DECISION MADE: 06-JUL-22 Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus DiaSorin Inc. 510(k) NO: K213858(Traditional) ATTN: Christa Blaisdell PHONE NO : 651 4399710 1951 Northwestern Ave SE DECISION MADE: 26-JUL-22 Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ennovate Cervical Spinal and Occiput System Aesculap Implant Systems, LLC. 510(k) NO: K213871(Traditional) ATTN: Paul Amudala PHONE NO : 610 4170839 3773 Corporate Parkway SE DECISION MADE: 01-JUL-22 Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ComPAS2 Morgan Scientific, Inc. 510(k) NO: K213872(Traditional) ATTN: Deborah Cornish PHONE NO : 978 5214440 151 Essex Street STE 8 SE DECISION MADE: 15-JUL-22 Haverhill MA 01832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SkyWalker Total Knee System MicroPort NaviBot International LL510(k) NO: K213873(Traditional) ATTN: Mike Manor PHONE NO : 508 5610097 300 Foxborough Blvd. SE DECISION MADE: 07-JUL-22 Foxborough MA 02035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Celerity Incubator STERIS Corporation 510(k) NO: K213881(Traditional) ATTN: Gregory Land PHONE NO : 440 3927424 5960 Heisley Road SE DECISION MADE: 21-JUL-22 Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin bioMerieux, Inc. 510(k) NO: K213899(Traditional) ATTN: Esther Hernandez PHONE NO : 314 7318841 595 Anglum Road SE DECISION MADE: 12-JUL-22 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Microstream CO2 NanoPod Covidien LLC 510(k) NO: K213911(Traditional) ATTN: Andrew Berkeland PHONE NO : 720 5017884 6135 Gunbarrel Ave SE DECISION MADE: 29-JUL-22 Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Injection Needle Jiangsu Vedkang Medical Science an510(k) NO: K213914(Traditional) ATTN: Ting Tang PHONE NO : 86 51969 8777918147 No. 52, Guoxiang Road, Wujin EconoSE DECISION MADE: 29-JUL-22 Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FX SPS Pixee Medical 510(k) NO: K213922(Traditional) ATTN: Agathe Joet PHONE NO : 33 4 58101365 18 rue Alain Savary SE DECISION MADE: 22-JUL-22 Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON MeMed BV, LIAISON MeMed BV Control Set DiaSorin Inc. 510(k) NO: K213936(Traditional) ATTN: John C. Walter PHONE NO : 651 4399710 1951 Northwestern Avenue SE DECISION MADE: 14-JUL-22 Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub Becton, Dickinson and Company 510(k) NO: K213955(Traditional) ATTN: Samhitha Mohan PHONE NO : 214 9710979 1 Becton Drive SE DECISION MADE: 16-JUL-22 Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TruAbutment DS, TruBase TruAbutment Inc. 510(k) NO: K213961(Traditional) ATTN: Hyeonhwa An PHONE NO : 714 9561488 17666 Fitch SE DECISION MADE: 14-JUL-22 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kontact Dental Implant System Biotech Dental, SAS 510(k) NO: K213997(Traditional) ATTN: Delphine Mercier PHONE NO : 33 049 0446060 305, Allées de Craponne SE DECISION MADE: 15-JUL-22 Salon de Provence FR 13300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: cvi42 Auto Imaging Software Application Circle Cardiovascular Imaging Inc 510(k) NO: K213998(Traditional) ATTN: Sydney Toutant PHONE NO : 1 403 2007706 Suite 1100 - 800 5th Ave SW SE DECISION MADE: 28-JUL-22 Calgary CA T2P 3T6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap Owens & Minor (O&M) Halyard, Inc. 510(k) NO: K214007(Traditional) ATTN: Anureet Singh PHONE NO : 470 4134225 9120 Lockwood Blvd SE DECISION MADE: 27-JUL-22 Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Examination gloves-Type A(Latex gloves) Jiangxi Kemei Medical Apparatus & 510(k) NO: K214017(Traditional) ATTN: Jenny Huang PHONE NO : 86 177 02094798 No. 316 National road, Xinju, ChanSE DECISION MADE: 14-JUL-22 Nanchang CN 331724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Oscar Peripheral Multifunctional Catheter system BIOTRONIK, Inc. 510(k) NO: K214038(Traditional) ATTN: Jon Brumbaugh PHONE NO : 888 3450374 6024 Jean Road SE DECISION MADE: 06-JUL-22 Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENT Nasopharyngoscope and Accessories Medimaging Integrated Solution Inc510(k) NO: K214050(Traditional) ATTN: Jung-Yi Yen PHONE NO : 886 357 98860 1706 3F., No.24-2, Industry E. Rd. IV, SE DECISION MADE: 01-JUL-22 Hsinchu TW 30077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pentaflush PENTAFERTE ITALIA S.R.L. 510(k) NO: K214080(Traditional) ATTN: Rosa Di Gioia PHONE NO : 390 86 1560201 Viale Piane Nocella, 23 SE DECISION MADE: 20-JUL-22 Campli Teramo IT 64012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Invia Ease Negative Pressure Wound Therapy (NPWT) System Medela AG 510(k) NO: K214112(Traditional) ATTN: Mike McAndrew PHONE NO : 1 815 5782376 Lattichstrasse 4b SE DECISION MADE: 26-JUL-22 Baar CH 6340 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel Becton, Dickinson and Company 510(k) NO: K214122(Traditional) ATTN: Joseph Basore PHONE NO : 616 3014068 7 Loveton Circle SE DECISION MADE: 28-JUL-22 Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ChoiceSpine Navigation System ChoiceSpine, LLC 510(k) NO: K220024(Traditional) ATTN: Kim Finch PHONE NO : 865 2433969 400 Erin Drive SE DECISION MADE: 06-JUL-22 Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AutoSeg AI Medic Inc. 510(k) NO: K220039(Traditional) ATTN: Jeong Soon Song PHONE NO : 82 256 82667 2F, 437, Bongeunsa-ro, Gangnam-gu SE DECISION MADE: 20-JUL-22 Seoul KR KS013/06097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems Medos International, SARL 510(k) NO: K220040(Traditional) ATTN: Michael Liao PHONE NO : 925 9998646 Chemin-Blanc 38 SE DECISION MADE: 14-JUL-22 Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelProcera Zirconia N1 Base Nobel Biocare Services AG 510(k) NO: K220048(Traditional) ATTN: Bernice Jim PHONE NO : 41 779 8550073 Balz Zimmermann-Str. 7 SE DECISION MADE: 29-JUL-22 Kloten CH 8302 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single Use Cytology Brush Zhejiang Chuangxiang Medical Techn510(k) NO: K220063(Traditional) ATTN: Lucius Long PHONE NO : 86 571 89167088 Room 101, 201, 301, 401, 501, BuilSE DECISION MADE: 28-JUL-22 Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synergy Marble (Model: Opasm) YRS Group Inc 510(k) NO: K220064(Traditional) ATTN: Raphael Arvili PHONE NO : 1 702 4268921 5151 S Procyon St Suite 105 SE DECISION MADE: 22-JUL-22 Las Vegas NV 89118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANNE Sleep Sibel Inc. 510(k) NO: K220095(Traditional) ATTN: Peter Xu PHONE NO : 224 25188590 6650 W. Touhy Ave. SE DECISION MADE: 11-JUL-22 Niles IL 60714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Neuronetics, Inc 510(k) NO: K220127(Traditional) ATTN: Cory Anderson PHONE NO : 404 4356781 3222 Phoenixville Pike SE DECISION MADE: 15-JUL-22 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biofeedback Nerve and Muscle Stimulator Shenzhen Konmed Technology Co.,Ltd510(k) NO: K220161(Traditional) ATTN: ShuiShan Yin PHONE NO : 86 136 03046428 601, Building B4, Shenchengtou CreSE DECISION MADE: 20-JUL-22 Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Northeast Scientific, Inc. 510(k) NO: K220171(Traditional) ATTN: Matthew Farley PHONE NO : 203 7562111 2142 Thomaston Ave. SE DECISION MADE: 01-JUL-22 Waterbury CT 06704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sterile Safety Syringes for Single Use (Retractable) Shanghai Kindly Enterprise Develop510(k) NO: K220183(Traditional) ATTN: Liu Hualong PHONE NO : 86 691 182328125 No. 658 Gaochao Road SE DECISION MADE: 21-JUL-22 Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pump Alignment Syringe Jiangsu Caina Medical Co., Ltd. 510(k) NO: K220184(Traditional) ATTN: Jianwei Pan PHONE NO : 86 510 86205183 No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 21-JUL-22 Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sterile Safety Insulin Syringes for Single Use Shanghai Kindly Enterprise Develop510(k) NO: K220185(Traditional) ATTN: Liu Hualong PHONE NO : 86 691 182328125 No. 658 Gaochao Road SE DECISION MADE: 11-JUL-22 Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle Anhui Tiankang Medical Technology 510(k) NO: K220204(Traditional) ATTN: Zhang Yong PHONE NO : 86 137 05505106 No.228,Weiyi Road, Economic DeveloSE DECISION MADE: 14-JUL-22 Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-Stem AMT LE Prosthesis DePuy Ireland UC 510(k) NO: K220216(Traditional) ATTN: Sarah Matamisa PHONE NO : Loughbeg, Ringaskiddy SE DECISION MADE: 22-JUL-22 Cork IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Home use hair removal device Shenzhen Mareal Tech Co., Ltd 510(k) NO: K220248(Traditional) ATTN: Liu Libin PHONE NO : 86 755 29980779 301,Building 1,No.2,Xiashiwei RoadSE DECISION MADE: 01-JUL-22 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) AVIA Vascular 510(k) NO: K220258(Traditional) ATTN: Kevin Cook PHONE NO : 801 8245375 6030 W Harold Gatty Dr. SE DECISION MADE: 14-JUL-22 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Examination Gloves (Blue) KGM Gloves Sdn. Bhd. 510(k) NO: K220284(Traditional) ATTN: Ooi Loon Seng PHONE NO : 60 12 4612918 Lot 18893 & 18894, Jalan PerusahaaSE DECISION MADE: 08-JUL-22 Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CerroZone Mobile CerroZone 510(k) NO: K220298(Traditional) ATTN: Marlon E. Robinson PHONE NO : P.O.Box 66800 SE DECISION MADE: 01-JUL-22 St. Louis MO 63166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PuraPly Micronized Wound Matrix (PuraPly MZ) Organogenesis Inc. 510(k) NO: K220317(Traditional) ATTN: Kurdea Lyon PHONE NO : 781 4011063 150 Dan Road SE DECISION MADE: 01-JUL-22 Canton MA 02021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 091 Balloon Guide Catheter InNeuroCo Inc. 510(k) NO: K220331(Traditional) ATTN: Marc Litzenberg PHONE NO : 954 4725988 19700 Stirling Road, Suite 1 SE DECISION MADE: 29-JUL-22 Pembroke Pines FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V Remex Medical Corporation 510(k) NO: K220348(Traditional) ATTN: Chuang Shih-Chang PHONE NO : 886 4 23595336 4F., No. 9, Jingke Road, Nantun DiSE DECISION MADE: 14-JUL-22 Taichung TW 408224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Protrieve Sheath Inari Medical, Inc. 510(k) NO: K220415(Traditional) ATTN: Kaitlyn Weinkauf PHONE NO : 949 4184116 6001 Oak Canyon, Suite 100 SE DECISION MADE: 12-JUL-22 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Through the Scope Tracheal Stent System Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K220424(Traditional) ATTN: Sally He PHONE NO : 86 25 58646395 No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22 Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Viz SDH Viz.ai, Inc. 510(k) NO: K220439(Traditional) ATTN: Vi Ma PHONE NO : 626 2363138 201 Mission St, 12th Floor SE DECISION MADE: 25-JUL-22 San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) Tianjin Huahong Technology Co., Lt510(k) NO: K220475(Traditional) ATTN: Yuan Ying PHONE NO : 1 530 2127671 A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 06-JUL-22 Tianjian CN 300308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Revogene Meridian Bioscience, Inc 510(k) NO: K220480(Traditional) ATTN: Jack Rogers PHONE NO : 513 2713700 638 3471 River Hills Drive SE DECISION MADE: 11-JUL-22 Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kentrospine PSS Pedicle Screw System Rivarp Medical Private Limited 510(k) NO: K220486(Traditional) ATTN: Sushma N.R PHONE NO : 080 23391136 No.34, Azeez Sait Industrial Town,SE DECISION MADE: 22-JUL-22 Bangalore IN 560039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline JK-Holding GmbH 510(k) NO: K220500(Traditional) ATTN: Juergen Gerstenmeier PHONE NO : 49 0 2224818330 Koehlershohner Strasse 60 SE DECISION MADE: 01-JUL-22 Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wet Essential95 Personal Lubricant Trigg Laboratories, Inc. 510(k) NO: K220534(Traditional) ATTN: Marla Bolden PHONE NO : 702 9574400 4220 W. Windmill Ln. Suite 140 SE DECISION MADE: 07-JUL-22 Las Vegas NV 89139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DolorClast Radial EMS Electro Medical Systems SA 510(k) NO: K220538(Traditional) ATTN: Timothée Deblock PHONE NO : 41 22 9948516 Ch. de la Vuarpilliere 31 SE DECISION MADE: 11-JUL-22 Nyon CH 1260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dermatac Drape 3M 510(k) NO: K220560(Traditional) ATTN: Melanie Avila PHONE NO : 210 2755038 6203 Farinon Drive SE DECISION MADE: 14-JUL-22 San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vascette HP (hemostatic pad) KOAG LLC 510(k) NO: K220566(Traditional) ATTN: David Lang PHONE NO : 470 7559291 790 Rarity Bay Pkwy SE DECISION MADE: 29-JUL-22 Vonore TN 37885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Noodle Pourang Bral, DDS, LLC 510(k) NO: K220573(Traditional) ATTN: Pourang Bral PHONE NO : 201 2644862 155 Albion Street SE DECISION MADE: 09-JUL-22 Passaic NJ 07055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dental Handpiece, Model CA160, CA160L, and CA500L Micro-NX Co., Ltd. 510(k) NO: K220577(Traditional) ATTN: Sojeong Park PHONE NO : 82 05 36501000 22 Maeyeo-ro 1 gil SE DECISION MADE: 29-JUL-22 Dong-gu KR 41059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 Ambu A/S 510(k) NO: K220606(Traditional) ATTN: Gurpreet Kaur Rehal PHONE NO : 45 266 08888 Baltorpbakken 13 SE DECISION MADE: 25-JUL-22 Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and 510(k) NO: K220619(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 4701003 LLC 9900 W. Innovation Drive SE DECISION MADE: 15-JUL-22 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hailie Sensor NF0106 Adherium (NZ) Ltd 510(k) NO: K220622(Traditional) ATTN: Geoff Feakes PHONE NO : 64 9 3072771 Level 11, 16 Kingston Street SE DECISION MADE: 15-JUL-22 Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AI4CMR v1.0 AI4MedImaging Medical Solutions S.510(k) NO: K220624(Traditional) ATTN: Carla Almeida PHONE NO : 93 507 7566 Rua do Parque Poente, Lote 35 SE DECISION MADE: 22-JUL-22 Braga PT 4705-002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NomadAir PMU810 Neurotronics, Inc. 510(k) NO: K220631(Traditional) ATTN: James "Cody" Smith PHONE NO : 352 3729955 4500 NW 27th Ave STE C2 SE DECISION MADE: 15-JUL-22 Gainesville FL 32606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets HTL-Strefa S.A. 510(k) NO: K220643(Traditional) ATTN: Justyna Zemigala PHONE NO : 48 42 2700010 Adamowek 7 SE DECISION MADE: 08-JUL-22 Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Prevena Restor Adapti-Form Dressing 3M Health Care Business Group 510(k) NO: K220660(Traditional) ATTN: Teri Feeley PHONE NO : 210 4591952 6203 Farinon Dr. SE DECISION MADE: 01-JUL-22 San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Manual Wheelchair Hebei Ruilangde Medical Equipment 510(k) NO: K220671(Traditional) ATTN: Liu Zhihao PHONE NO : 86 134 75165790 Zhongkuang S. Rd., High-tech DevelSE DECISION MADE: 21-JUL-22 Hengshui CN 053599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pediatric Nailing Platform | Femur OrthoPediatrics Corp. 510(k) NO: K220679(Traditional) ATTN: Yan Li PHONE NO : 574 2670864 2850 Frontier Drive SE DECISION MADE: 20-JUL-22 Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OptiVu ROSA MxR Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K220733(Traditional) ATTN: Paul Hardy PHONE NO : 574 4536739 75 Queen St., Suite 3300 SE DECISION MADE: 29-JUL-22 Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NxtGen Infant Transport Incubator International Biomedical 510(k) NO: K220742(Traditional) ATTN: Amy Pieper PHONE NO : 512 8730033 8206 Cross Park Drive SE DECISION MADE: 15-JUL-22 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CediTEC VOCO GmbH 510(k) NO: K220743(Traditional) ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190 Anton-Flettner-Str. 1-3 SE DECISION MADE: 05-JUL-22 Cuxhaven DE 27472 510(k) STATEMENT DEVICE: Stratasys TrueDent Stratasys Ltd 510(k) NO: K220771(Traditional) ATTN: Melanie Glennon PHONE NO : 972 74 7454000 1 Holtzman St. Science Park P.O. BSE DECISION MADE: 07-JUL-22 Rehovot IL 7612401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical face mask Hubei Qianjiang Kingphar Medical M510(k) NO: K220777(Traditional) ATTN: Zhao Fusong PHONE NO : 86 133 49716939 Yuanguang Road SE DECISION MADE: 19-JUL-22 Qianjiang CN 433100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. 510(k) NO: K220784(Traditional) ATTN: Sindhu Sridhar PHONE NO : 1 442 9997630___ 2210 Faraday Ave, Suite 100 SE DECISION MADE: 01-JUL-22 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tigertriever 13 Revascularization Device Rapid Medical Ltd. 510(k) NO: K220808(Traditional) ATTN: Orit Yaniv PHONE NO : 972 72 2503331___ Carmel Building, POB 337 SE DECISION MADE: 25-JUL-22 Yokneam IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAEOTOM Alpha, Scan&GO Software Siemens Medical Solutions USA, Inc510(k) NO: K220814(Traditional) ATTN: Tabitha Estes PHONE NO : 865 8044553 810 Innovation Drive SE DECISION MADE: 12-JUL-22 Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BrainInsight Hyperfine, Inc. 510(k) NO: K220815(Traditional) ATTN: Christine Kupchick PHONE NO : 203 3433404 351 New Whitfield St SE DECISION MADE: 19-JUL-22 Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves American Nitrile Operations LLC 510(k) NO: K220825(Abbreviated) ATTN: Stephen Perrin PHONE NO : 937 9645559 3500 Southwest Blvd SE DECISION MADE: 08-JUL-22 Grove City OH 43123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Electric Wheelchair Foshan Dahao Medical Technology C510(k) NO: K220827(Traditional) ATTN: Bao Yi Xie PHONE NO : 86 137 60674304 Building 1, 2nd Floor of Building SE DECISION MADE: 05-JUL-22 Foshan CN 528137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-GPS Navigated Instruments Precision Spine, Inc. 510(k) NO: K220862(Traditional) ATTN: Michael Dawson PHONE NO : 601 4204244 2050 Executive Dr. SE DECISION MADE: 14-JUL-22 Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOK 95A Medical Mask (20200049) AOK Tooling Limited 510(k) NO: K220876(Traditional) ATTN: Francis Nithyananthan PHONE NO : 852 0 23101703 Flat 2009, 20/F, Kowloon Plaza, NoSE DECISION MADE: 27-JUL-22 Cheung Sha Wan, Kowloon CN 518122510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems Lumenis Be, Inc. 510(k) NO: K220877(Traditional) ATTN: Shlomit Segman PHONE NO : 972 4 9599230 1870 South Milestone Drive SE DECISION MADE: 15-JUL-22 Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and 510(k) NO: K220882(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 4701003 Primary Care Diagnostics, LLC 9900SE DECISION MADE: 22-JUL-22 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Upper Arm Type Blood Pressure Monitor Shenzhen Jamr Technology Co.,Ltd 510(k) NO: K220886(Traditional) ATTN: Luo Fusheng PHONE NO : 86 755 85292057 A101-301,D101-201, Jamr Science & SE DECISION MADE: 27-JUL-22 Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-Core Implant System Subchondral Solutions, Inc. 510(k) NO: K220901(Traditional) ATTN: Michael Kolber PHONE NO : 408 5056626 7146 Edinger Ave. Suite A SE DECISION MADE: 29-JUL-22 Huntington Beach CA 92647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURE-LOCK Xiros Ltd 510(k) NO: K220906(Traditional) ATTN: Steve Curran PHONE NO : 44 113 2387200 Springfield House Lane, WhitehouseSE DECISION MADE: 22-JUL-22 Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit Cochlear Americas 510(k) NO: K220922(Traditional) ATTN: Samata Veluvolu PHONE NO : 302 5426468 10350 Park Meadows Drive SE DECISION MADE: 27-JUL-22 Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EchoPAC Software Only, EchoPAC Plug-in GE Medical Systems Ultrasound and 510(k) NO: K220940(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 4701003 LLC 9900 W. Innovation Drive SE DECISION MADE: 22-JUL-22 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim ECO Medi Glove Sdn.Bhd. 510(k) NO: K220943(Traditional) ATTN: Suresh Kumar PHONE NO : 605 8062316 Lot 23826, Jalan Tembaga Kuning, KSE DECISION MADE: 19-JUL-22 Taiping MY 34600 510(k) STATEMENT DEVICE: Libby Echo:Prio Dyad Medical, Inc 510(k) NO: K220956(Traditional) ATTN: Ronny Shalev PHONE NO : 617 4809569 215 Brighton Avenue, Suite 203 SE DECISION MADE: 20-JUL-22 Boston MA 02134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Real Intelligence Cori Blue Belt Technologies, Inc. 510(k) NO: K220958(Traditional) ATTN: Unnati Bhuptani PHONE NO : 412 8536682 2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 27-JUL-22 Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Deep Learning Image Reconstruction GE Healthcare Japan Corporation 510(k) NO: K220961(Special) ATTN: Wang Xing PHONE NO : 86 10 57388271 7-127, 4-Chome, Asahigaoka SE DECISION MADE: 29-JUL-22 Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Renuvion APR Handpiece Apyx Medical Corporation(formerly 510(k) NO: K220970(Traditional) ATTN: Priscilla Herpai PHONE NO : 610 5337984 5115 Ulmerton Road SE DECISION MADE: 15-JUL-22 Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Life Scope PT BSM-1700 Series Bedside Monitor Nihon Kohden Corporation 510(k) NO: K220976(Special) ATTN: Sandra Gadeyne PHONE NO : 949 3563401 1-31-4 Nishiochiai, Shinjuki-Ku SE DECISION MADE: 21-JUL-22 Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Next Generation NetKonnect Nihon Kohden Digital Health Soluti510(k) NO: K220989(Special) ATTN: Maria Pronina PHONE NO : 949 5919596 14 Bunsen SE DECISION MADE: 29-JUL-22 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Ost510(k) NO: K221019(Traditional) ATTN: Andrea Del Ciotto PHONE NO : 61 408 583222 759-767 Springvale Road SE DECISION MADE: 05-JUL-22 Mulgrave AU 3170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: i_ Field 1.5T Superconducting Magnetic Resonance Imaging System MRI Division,Beijing Wandong Medic510(k) NO: K221025(Traditional) ATTN: Wang Huan PHONE NO : 86 10 65794660 No.38, Chaoyang Road, Chaoyang DisSE DECISION MADE: 01-JUL-22 Beijing CN 100024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Power Wheelchair Zhejiang Innuovo Rehabilitation De510(k) NO: K221026(Traditional) ATTN: Leo Zheng PHONE NO : 86 183 58936043 No.196 Industry Road, Hengdian MovSE DECISION MADE: 01-JUL-22 Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGIVISIO Device Ecential Robotics 510(k) NO: K221028(Traditional) ATTN: Sarah Lefevre-Billard PHONE NO : 0033 4 58005721 Zone Mayencin II, Parc Equation - SE DECISION MADE: 06-JUL-22 Gieres FR 38610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Model 9100 PFT/DICO Vitalograph Ireland Ltd. 510(k) NO: K221030(Traditional) ATTN: Tony O'Hanlon PHONE NO : 353 65 6864100 Gort Road Business Park SE DECISION MADE: 15-JUL-22 Ennis Co Clare IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UniPrime A, UniPrime E, UniPrime E/C S&C Polymer Silicon- und Composite510(k) NO: K221033(Traditional) ATTN: Christian Böttcher PHONE NO : 49 4121 4830 Robert-Bosch-Str. 2 SE DECISION MADE: 06-JUL-22 Elmshorn DE 25335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Astroglide Warming BioFilm Inc. 510(k) NO: K221036(Traditional) ATTN: Kevin Jamil PHONE NO : 760 7279030 3225 Executive Ridge SE DECISION MADE: 01-JUL-22 Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TruDi Shaver Blade Acclarent, Inc. 510(k) NO: K221037(Traditional) ATTN: Leena Zalavadia PHONE NO : 1 949 9234118 31 Technology Drive, Suite 200 SE DECISION MADE: 20-JUL-22 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Changsha Honchon Technology Co., L510(k) NO: K221051(Traditional) ATTN: Ling Li PHONE NO : 86 731 85529297 Room 627-628, Building 3th, JinqiaSE DECISION MADE: 08-JUL-22 Changsha CN 410200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Smartlux Mini MEDMIX Co., Ltd. 510(k) NO: K221083(Traditional) ATTN: Yunseok Yu PHONE NO : 82 10 94878160 B-707 Smartvalley, 30, SongdomiraeSE DECISION MADE: 12-JUL-22 Incheon KR 21990 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SmileSeries Ordont Orthodontic Laboratories, I510(k) NO: K221097(Traditional) ATTN: Paul Rudzicka PHONE NO : 800 3253698 1755 Smizer Station Road SE DECISION MADE: 14-JUL-22 Fenton MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit Stryker Corporation 510(k) NO: K221098(Traditional) ATTN: Maya Schiel PHONE NO : 49 30 31199189 Boetzinger Strasse 41 SE DECISION MADE: 12-JUL-22 Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Medical Examination Gloves Anhui Fulewei Electronic Technolog510(k) NO: K221108(Traditional) ATTN: Beina Gong PHONE NO : 86 1505 5553699 South Of Binheroad, West Of GangkoSE DECISION MADE: 12-JUL-22 Fuyang CN 236000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid T8, Vivid T9 GE Medical Systems Ultrasound and 510(k) NO: K221147(Traditional) ATTN: Lee Bush PHONE NO : 262 3099429 LLC 9900 W. Innovation Drive SE DECISION MADE: 18-JUL-22 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid iq GE Medical Systems Ultrasound & Pr510(k) NO: K221148(Traditional) ATTN: Lee Bush PHONE NO : 262 3099429 9900 W. Innovation Drive SE DECISION MADE: 18-JUL-22 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Beauty LED Mask, Model: KFB265 Hunan Guangye Biotechnology Co., L510(k) NO: K221151(Traditional) ATTN: Eileen Li PHONE NO : 86 0755 89373426 Room 701, Jinhong Park Incubation SE DECISION MADE: 19-JUL-22 Changsha City CN 410006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Mask (Model: 0868F, 0866F) Jiangxi SanHao Medical Instruments510(k) NO: K221173(Traditional) ATTN: Jiali Chen PHONE NO : 86 151 79660192 Chengxi Industrial Park, Jishui CoSE DECISION MADE: 06-JUL-22 Ji'an CN 331699 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Insulin Pen Needle Tianjin Huahong Technology Co., Lt510(k) NO: K221176(Special) ATTN: Yuan Ying PHONE NO : 1 530 2127671 A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 01-JUL-22 Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Medical Face Mask (ear loop) Xiantao Topmed Nonwoven Protective510(k) NO: K221196(Traditional) ATTN: Vivian Zhu PHONE NO : 86 2787 861070 North of the National Road 318, ToSE DECISION MADE: 22-JUL-22 Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AHI System Fifth Eye Inc. 510(k) NO: K221203(Special) ATTN: Jennifer Baird PHONE NO : 734 2604800 110 Miller Avenue, Suite 300 SE DECISION MADE: 14-JUL-22 Ann Arbor MI 48104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves Zibo Blue Sail Health Technology C510(k) NO: K221229(Traditional) ATTN: Xu Shulong PHONE NO : 0086 533 7859085 No.1888 Honghua Road, High TechnicSE DECISION MADE: 16-JUL-22 Zibo CN 255400 510(k) STATEMENT DEVICE: TRON Xoran Technologies LLC 510(k) NO: K221230(Traditional) ATTN: Mark McGarrow PHONE NO : 734 4185125 5210 S. State Rd. SE DECISION MADE: 28-JUL-22 Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TargetCool RecensMedical Inc. 510(k) NO: K221234(Traditional) ATTN: Yeonui Lee PHONE NO : 82 31 80433064__ 908, SK V1 center, 830 DongtansunhSE DECISION MADE: 22-JUL-22 Hwaseong-si KR 18468 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: neXus Ultrasonic Surgical Aspirator System Misonix Inc. 510(k) NO: K221235(Traditional) ATTN: John Salerno PHONE NO : 1 631 6949555 1938 New Highway SE DECISION MADE: 28-JUL-22 Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Hunan Vsmile Biotechnology Co., Lt510(k) NO: K221242(Traditional) ATTN: Xiaomi Tang PHONE NO : 86 731 85682958 Juxing 501-5,501-6, Lujing Road NoSE DECISION MADE: 29-JUL-22 Changsha CN 410000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) Shenzhen Semlamp Intelligent Techn510(k) NO: K221246(Traditional) ATTN: Qi Wenjun PHONE NO : 86 1342 8733261 Room 915, Lankun Building, MinkangSE DECISION MADE: 07-JUL-22 Shenzhen CN 518131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) Guangzhou Hua Kai Electronic Techn510(k) NO: K221251(Traditional) ATTN: Cao Ke PHONE NO : 86 020 82061985 4th Floor, Building 8, No.39 Bi GaSE DECISION MADE: 29-JUL-22 Guangzhou CN 510730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hummingbird Tympanostomy Tube System Preceptis Medical, Inc. 510(k) NO: K221254(Traditional) ATTN: Steve Anderson PHONE NO : 763 5687809 10900 89th Avenue North, Suite 4 SE DECISION MADE: 27-JUL-22 Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System Dexcom, Inc. 510(k) NO: K221259(Special) ATTN: Rachel Ellena PHONE NO : 858 2036046 6340 Sequence Dr. SE DECISION MADE: 29-JUL-22 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Better Care Plastic Technology Co.510(k) NO: K221269(Traditional) ATTN: Zhu Chunyan PHONE NO : 86 311 66766067 Fuqian Xi Road, West district of SSE DECISION MADE: 27-JUL-22 Shenze County CN 050000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) Shandong Maida Medical Technology 510(k) NO: K221271(Traditional) ATTN: Kitty Xu PHONE NO : 86 1385 3370291 Room 102, Eastern building, No.166SE DECISION MADE: 27-JUL-22 Dongying CN 257000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-Brik Visualization Assistant JDI Surgical, Inc. 510(k) NO: K221293(Traditional) ATTN: Dwight Lenox PHONE NO : 720 3713071 9925 Silver Maple Way SE DECISION MADE: 07-JUL-22 Highlands Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoCentric Spine MIS Pedicle Fastener System OsteoCentric Technologies 510(k) NO: K221332(Traditional) ATTN: Todd Evans PHONE NO : 435 7572253 75 West 300 N, Suite 150 SE DECISION MADE: 28-JUL-22 Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Materialise TKA Guide System Materialise NV 510(k) NO: K221337(Traditional) ATTN: Jenny Jones PHONE NO : 32 16 396611 Technologielaan 15 SE DECISION MADE: 05-JUL-22 Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Stryker VariAx 2 MIS Calcaneus Stryker GmbH 510(k) NO: K221346(Traditional) ATTN: Jonathan Schell PHONE NO : 484 8895804 325 Corporate Drive SE DECISION MADE: 08-JUL-22 Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AF Laser ShenB Co Ltd 510(k) NO: K221363(Traditional) ATTN: Sunny Kang PHONE NO : 82 70 49122702 ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 20-JUL-22 Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mitek TIGHT-N Anchor Medos International SARL 510(k) NO: K221364(Traditional) ATTN: Ashley Aromando (Goncalo) PHONE NO : 508 9773907 Chemin-Blanc 38, Case Postale SE DECISION MADE: 11-JUL-22 Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14HQ701G-B LG Electronics Inc. 510(k) NO: K221394(Traditional) ATTN: Jinhwan Jun PHONE NO : 82 31 80665641 77, Sanho-daero SE DECISION MADE: 22-JUL-22 Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Footmotion Plating System Newclip Technics 510(k) NO: K221395(Traditional) ATTN: Gaëlle Lussori PHONE NO : 33 228 213712 P.A. de la Lande Saint Martin - 45SE DECISION MADE: 01-JUL-22 Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIP™ MIS Interspinous Fusion System Aurora Spine, Inc. 510(k) NO: K221399(Traditional) ATTN: Laszlo Garamszegi PHONE NO : 760 4242004 1930 Palomar Point Way, Suite #103SE DECISION MADE: 08-JUL-22 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) Conformis Inc. 510(k) NO: K221404(Traditional) ATTN: Mary Kruitwagen PHONE NO : 781 3459038 600 Technology Park Drive, 4th FloSE DECISION MADE: 26-JUL-22 Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: truSculpt iD Cutera Inc. 510(k) NO: K221407(Traditional) ATTN: Amogh Kothare PHONE NO : 415 6906796 3240 Bayshore Blvd. SE DECISION MADE: 13-JUL-22 Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Paneffort 3-ply Surgical and Procedural Masks Paneffort, LLC 510(k) NO: K221409(Traditional) ATTN: Harry No Last Name ProvidedPHONE NO : 855 12284810 700 Elmridge Center Drive SE DECISION MADE: 25-JUL-22 Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Functional MR V1.0 Olea Medical SAS 510(k) NO: K221426(Traditional) ATTN: Nathalie Palumbo PHONE NO : 33 4 42712420 93 Avenue des Sorbiersm ZI ATHELIASE DECISION MADE: 06-JUL-22 La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KDF Zirconia Disc DENKEN-HIGHDENTAL Co., Ltd. 510(k) NO: K221429(Traditional) ATTN: Daijiro Goto PHONE NO : 81 75 6722124 24-3 SE DECISION MADE: 14-JUL-22 Kisshoin Ishiharakyomichi-cho, Min510(k) SUMMARY AVAILABLE FROM FDA DEVICE: reVive Light Therapy LED Cleansing System LED Technologies, Inc. 510(k) NO: K221430(Special) ATTN: Jelena Barbaric PHONE NO : 303 8450028 12821 Starkey Rd., Suite 4900 SE DECISION MADE: 27-JUL-22 Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant Church & Dwight Co., Inc. 510(k) NO: K221431(Traditional) ATTN: Supreet Sahota-Bhatti PHONE NO : 609 8067893 500 Charles Ewing Blvd. SE DECISION MADE: 14-JUL-22 Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Facet 28G Universal Lancet Facet Technologies LLC 510(k) NO: K221433(Traditional) ATTN: James Bonds PHONE NO : 770 5906462 3900 N. Commerce Dr. SE DECISION MADE: 15-JUL-22 Atlanta GA 30344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 17HQ701G-B LG Electronics Inc. 510(k) NO: K221434(Traditional) ATTN: Jinhwan Jun PHONE NO : 82 31 80665641 77, Sanho-daero SE DECISION MADE: 13-JUL-22 Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Medical Nitrile Examination Gloves - Non Sterile Guangzhou Kangling Biotechnology C510(k) NO: K221454(Traditional) ATTN: Yan Wang PHONE NO : 86 208 7866619 Baiyun Avenue,Yongping Street,BaiySE DECISION MADE: 12-JUL-22 Guangzhou CN 510440 510(k) STATEMENT DEVICE: BioFire COVID-19 Test 2 BioFire Defense, LLC 510(k) NO: K221460(Special) ATTN: Cynthia Phillips PHONE NO : 801 2623592 1370 79 W 4500 S, Suite 14 SE DECISION MADE: 25-JUL-22 Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 10HQ701G-B LG Electronics Inc. 510(k) NO: K221461(Traditional) ATTN: Jinhwan Jun PHONE NO : 82 31 80665641 77, Sanho-daero SE DECISION MADE: 22-JUL-22 Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CorPath GRX System Corindus, Inc. 510(k) NO: K221464(Special) ATTN: Robert Lavado PHONE NO : 978 7607727 309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-JUL-22 Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Parcus Synd-EZ SS Parcus Medical, LLC 510(k) NO: K221502(Traditional) ATTN: Vasavi Vora PHONE NO : 6423 Parkland Drive SE DECISION MADE: 26-JUL-22 Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) Vieworks Co., Ltd. 510(k) NO: K221512(Traditional) ATTN: Kevin Oh PHONE NO : 82 70 44663220 41-3, Burim-ro 170beon-gil, DonganSE DECISION MADE: 20-JUL-22 Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIS icono (Ceiling Configuration) Siemens Medical Solutions USA, Inc510(k) NO: K221516(Traditional) ATTN: Patricia D. Jones PHONE NO : 678 5758832 40 Liberty Boulevard SE DECISION MADE: 19-JUL-22 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PreXion3D Explorer PRO PreXion Corporation 510(k) NO: K221525(Traditional) ATTN: Hiroaki Takahashi PHONE NO : 81 3 52977551 1-14-1, Kandasuda-cho SE DECISION MADE: 22-JUL-22 Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Align Lumbar Interbody Fusion System Acuity Surgical Devices, LLC 510(k) NO: K221535(Traditional) ATTN: Bryan Cowan PHONE NO : 844 2284890 8710 N. Royal Lane SE DECISION MADE: 22-JUL-22 Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) Qingdao Hisense Medical Equipment 510(k) NO: K221567(Traditional) ATTN: Li Mingcheng PHONE NO : 86 532 83091111 No. 399 Songling Road, Laoshan DisSE DECISION MADE: 26-JUL-22 Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VyPlate Anterior Cervical Plate System Vy Spine, LLC 510(k) NO: K221572(Traditional) ATTN: Jordan Hendrickson PHONE NO : 866 4897746 2236 Capital Circle NE, Suite 103-SE DECISION MADE: 26-JUL-22 Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2-Way 100% Silicone ClearTract Catheter Silq Technologies Corporation 510(k) NO: K221625(Special) ATTN: Sigi Caron PHONE NO : 831 3466970 323 Sunny Isles Blvd SE DECISION MADE: 01-JUL-22 Sunny Isles Beach FL 33160 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: medi pneumatic compression system (pcs)-genius (Model 652) medi USA, L.P. 510(k) NO: K221654(Third Party - Traditional) ATTN: Moses Lipshaw PHONE NO : 336 4494440 229 6481 Franz Warner Parkway SE DECISION MADE: 07-JUL-22 Whitsett NC 27377-9214 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Normatec Go NormaTec Industries, LP 510(k) NO: K221666(Third Party - Traditional) ATTN: Steve Henderson PHONE NO : 800 3350906 480 Pleasant Street, Suite A200 SE DECISION MADE: 14-JUL-22 Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IPL Hair Remover, Model: G993, G996, G998 and G885 Shenzhen Mywin Technology Co., Ltd510(k) NO: K221679(Special) ATTN: Meiyun Liu PHONE NO : 86 18902 842323 2nd Floor, Building B, New Age gonSE DECISION MADE: 07-JUL-22 Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pegasus-X Expandable PLIF System GS Medical Co. Ltd. 510(k) NO: K221687(Traditional) ATTN: Sam Camp PHONE NO : 352 3274641 90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 27-JUL-22 Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc510(k) NO: K221727(Special) ATTN: Monsuru Bello PHONE NO : 202 8566099 810 innovation Drive SE DECISION MADE: 13-JUL-22 Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation 510(k) NO: K221763(Special) ATTN: Alexandra Wells PHONE NO : 609 9036300 1100 Campus Rd SE DECISION MADE: 15-JUL-22 Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid ONETEXX SDN BHD 510(k) NO: K221773(Traditional) ATTN: Freddy Low PHONE NO : 605 8070666 No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 30-JUL-22 Kamunting MY 34600 510(k) STATEMENT DEVICE: Vario-Cup System Waldemar Link GmbH & Co. KG 510(k) NO: K221794(Special) ATTN: Pia Mueller PHONE NO : 49 40 53575530 Oststraße 4-10 SE DECISION MADE: 20-JUL-22 Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. SEDECAL SA 510(k) NO: K221803(Special) ATTN: Ma Luisa Gomez de Aguero PHONE NO : 34 91 6280544 C/ Pelaya, 9 – 13 Pol. Ind. Río deSE DECISION MADE: 18-JUL-22 Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OK Handpiece Jaintek Co.,Ltd 510(k) NO: K221814(Third Party - Traditional) ATTN: Jung Gun Lee PHONE NO : 82 31 4959091 #302, 419, Byeolmang-ro, Danwon-guSE DECISION MADE: 15-JUL-22 Ansan-si KR 15605 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Cionic Neural Sleeve NS-100 CIONIC 510(k) NO: K221823(Special) ATTN: Mihai Ionescu PHONE NO : 1 831 8244051 1606 Stockton St, Suite #1 SE DECISION MADE: 21-JUL-22 San Francisco CA 94133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Artix Ballon Guiding Sheath Inari Medical 510(k) NO: K221846(Third Party - Traditional) ATTN: Elllen Nguyen PHONE NO : 949 4184127 6001 Oak Canyon Suite 100 SE DECISION MADE: 11-JUL-22 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OTC DDR Konica Minolta Healthcare Americas510(k) NO: K221853(Special) ATTN: Jan Maniscalco PHONE NO : 973 6331500 2217 US Highway 70 East SE DECISION MADE: 27-JUL-22 Garner NC 27529 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMONITOR IIIm, BIOMONITOR III BIOTRONIK, Inc. 510(k) NO: K221856(Special) ATTN: Jon Brumbaugh PHONE NO : 888 3450374 6024 Jean Road SE DECISION MADE: 27-JUL-22 Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1 Canon Inc. 510(k) NO: K221876(Special) ATTN: Akira Hirai PHONE NO : 81 33 7582111 9-1 Imaikami-cho, Nakahara-ku, SE DECISION MADE: 15-JUL-22 Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder-Free Nitrile Examination Glove, Non-Sterile GoodGloves Industries Sdn Bhd 510(k) NO: K221877(Third Party - Traditional) ATTN: Yee Kam Lin PHONE NO : PT 12678, Jalan Techvalley 2, SendSE DECISION MADE: 23-JUL-22 Seremban MY 71950 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Gastrointestinal Boundary Identifier (GIBI HD) ReShape Lifesciences 510(k) NO: K221898(Special) ATTN: Michelle Ravert PHONE NO : 949 4817851 1001 Calle Amanecer SE DECISION MADE: 28-JUL-22 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EleGARD AdvancedCPR Solutions LLC 510(k) NO: K221901(Special) ATTN: Philip Faris PHONE NO : 210 5086647 5201 Eden Avenue Suite 300 SE DECISION MADE: 29-JUL-22 Edina MN 55436 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INERTIA CONNEXX Modular Pedicle Screw System Nexxt Spine LLC 510(k) NO: K221905(Special) ATTN: Andy Elsbury PHONE NO : 317 4367801 14425 Bergen Blvd Suite B SE DECISION MADE: 28-JUL-22 Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RhinAer® Stylus (FG1393) Aerin Medical Inc. 510(k) NO: K221907(Special) ATTN: Shannon Scott PHONE NO : 512 2219956 2565 Leghorn St. SE DECISION MADE: 29-JUL-22 Mountain View CA 91043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: J-Temp Ultradent Products, Inc. 510(k) NO: K221909(Third Party - Traditional) ATTN: Matthew Buck PHONE NO : 801 5534339 505 W Ultradent Drive (10200 SouthSE DECISION MADE: 01-JUL-22 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Catapult Guide Sheath Contract Medical International Gmb510(k) NO: K221914(Special) ATTN: Juliana Vaz Nuernberger PHONE NO : 49 351 21074719 Lauensteiner Strasse 37 SE DECISION MADE: 29-JUL-22 Dresden DE 01277 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trinias Shimadzu Corporation Medical Syste510(k) NO: K221922(Special) ATTN: Koichi Kataoka PHONE NO : 81 75 8231305 1, Nishinokyo-Kuwabaracho, NakagyoSE DECISION MADE: 28-JUL-22 Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Swoop Portable MR Imaging System Hyperfine, Inc. 510(k) NO: K221923(Special) ATTN: Christine Kupchick PHONE NO : 203 3433404 351 New Whitfield Street SE DECISION MADE: 28-JUL-22 Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cemented Round Patella with JRNY Pegs Smith & Nephew, Inc. 510(k) NO: K221939(Special) ATTN: Madison Padgett PHONE NO : 901 4568789 7135 Goodlett Farms Parkway SE DECISION MADE: 26-JUL-22 Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm Conmed Corporation 510(k) NO: K221945(Special) ATTN: Kavita Amin PHONE NO : 508 9482084 11311 Concept Blvd SE DECISION MADE: 28-JUL-22 Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXALT Model B Single-Use Bronchoscope Boston Scientific Corporation 510(k) NO: K222014(Special) ATTN: Carter Navarro PHONE NO : 508 3820356 100 Boston Scientific Way SE DECISION MADE: 28-JUL-22 Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biotres Biotricity 510(k) NO: K222017(Special) ATTN: Spencer LaDow PHONE NO : 585 4147407 203 Redwood Shores Pkwy Suite 600 SE DECISION MADE: 28-JUL-22 Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Selectra Lead Implantation System Biotronik, Inc. 510(k) NO: K222037(Special) ATTN: Jon Brumbaugh PHONE NO : 888 3450374 6024 Jean Road SE DECISION MADE: 19-JUL-22 Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 251 TOTAL WITH STATEMENTS 6