FDA 510(k) Decisions During September, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K193599 09/03/2020 BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair 21st Century Scientific, Inc. RD Davidson
K200835 09/04/2020 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 3M Company Hilary B. Hovde
K202256 09/09/2020 3Shape Implant Studio 3Shape Medical A/S Jenny Axel
K201966 09/03/2020 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array 7D Surgical Inc. Daniel Zisind
K192665 09/15/2020 Accelerate Pheno System, Accelerate PhenoTest BC Kit Accelerate Diagnostics, Inc. Carrene Plummer
K201948 09/09/2020 AcroDTI Visualizer AcroViz Inc. Yung-Chin Hsu
K201194 09/08/2020 Acuity 200Ö (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K201341 09/15/2020 AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. Karla Schaffner
K201494 09/17/2020 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card Advin Biotech, Inc. Daniel Hsu
K202124 09/02/2020 Aesculap PAS-Port Proximal Anastomosis System Aesculap Inc. Sierra Mertz
K201631 09/14/2020 VersaWrap Nerve Protector Alafair Biosciences Inc Angela Mallery
K201203 09/03/2020 Cliq Aspirator Anest Iwata Sparmax Co., Ltd. Lika Lo
K202347 09/15/2020 UNIFUSE Infusion System with Cooper Wire AngioDynamics, Inc. Brandon M. Brackett
K191639 09/11/2020 TK Insulin Syringe with/without Saftey Retractable Device Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong
K201517 09/04/2020 Plain Surgical Mask AOK Tooling Limited Francis Nithyananthan
K201552 09/02/2020 ApolloVue S100 Image System Apollo Medical Optics, Ltd. Chi-Hua Wu
K201677 09/02/2020 Arthrex Mesh Plates Arthrex Inc. Rebecca R Homan
K201522 09/03/2020 Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Arthrex Inc. Rebecca R. Homan
K201134 09/04/2020 Arthrex NanoScope System Arthrex, Inc. Heli F Chambi Infantas
K202252 09/08/2020 ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K200641 09/03/2020 HaloGUARD Protective Disc with CHG ATTWILL Medical Solutions Attilio Di Fiore
K201779 09/11/2020 HotDog Temperature Management Controller Augustine Temperature Management Temi Ogunse
K201330 09/10/2020 Tigereye CTO-Crossing Catheter Avinger, Inc. Thomas Lawson
K201532 09/19/2020 B&J DVT Calf/Thigh Garments, Models 801/830 Series B & J Manufacturing Ltd. Billy Yu
K201547 09/18/2020 B&J DVT Foot Garments, Models 820 Series B&J Manufacturing Ltd. Billy Yu
K201539 09/09/2020 Keeogo Dermoskeleton System B-Temia Inc. Alexandre Jokic
K192452 09/03/2020 Lyograft B. Bruan Surgical, SA Pau Turon Dols
K192538 09/04/2020 BD Syringe NRFit Lok and BD Syringe NRFit Slip Becton, Dickinson and Company Murtaza Rana
K200462 09/02/2020 EtchPro Etching Gel Belport Company, Inc., Gingi-Pak Daniel Wang
K202008 09/10/2020 Disposable Vinyl Glove Best Care Trading Co., LTD Chongfeng Zhao
K201350 09/20/2020 CORVUS Best Nomos Vineet Gupta
K192730 09/09/2020 CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV BioSystems S.A. Noelia Gil
K193618 09/02/2020 ExactechGPS System Blue Ortho Matthieu Coic
K201170 09/15/2020 Athletis PTA Balloon Dilatation Catheter Boston Scientific Corporation Jennifer Mrkvicka
K193424 09/01/2020 Resolution 360Ö ULTRA Clip Boston Scientific Corporation Elena Hennessey
K202406 09/16/2020 Butterfly iQ Ultrasound System Butterfly Network, Inc. Brian Sawin
K192822 09/09/2020 Benesta Hysteroscope Caldera Medical, Inc. Vicki Gail
K201992 09/18/2020 Caption Guidance Caption Health Sam Surette
K201738 09/10/2020 SubNovii Advanced Plasma Technology Cartessa Aesthetics Gabe Lubin
K200313 09/14/2020 VIVO Catheter Precision, Inc. Steve Adler
K201642 09/18/2020 Paragon Adult Maxi PMP Oxygenator with Tubing Pack Chalice Medical Ltd Stephen Horan
K202235 09/03/2020 ArtPIX DRF CMT Medical Technologies Ltd Dror Wertman
K201859 09/11/2020 Porcine Mineral Collagen Composite Moldable Collagen Matrix, Inc. Gloria Zuclich
K201849 09/17/2020 eNAT molecular collection and preservation medium Copan Italia S.p.A. Elena Simeonato
K201333 09/11/2020 SABER .035 PTA Dilatation Catheter Cordis Corporation Kyungyoon Kang
K190561 09/04/2020 NICU V'02 COSMED Nordic ApS Peter Clemensen
K200916 09/01/2020 Patient Administration Set Cyclomedica Australia Pty Ltd Niamh Mc Aree
K193341 09/04/2020 iCTmotor (WL-1) Dentium Co., Ltd Sangwoo Lee
K200102 09/03/2020 MIS Dental Implant System Dentsply Sirona Karl Nittinger
K193405 09/02/2020 Simplant Digital Guide Dentsply Sirona Karl Nittinger
K200854 09/11/2020 DePuy PINNACLE Dual Mobility Liner DePuy Ireland UC Erin Combs
K201959 09/11/2020 DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System DePuy Synthes Stacey Bonnell
K200174 09/18/2020 DIA-ROOT BIO MTA Diadent Group International Kab Sun Lee
K202499 09/03/2020 Diamond Digital Sleep Orthotic (DDSO) Diamond Orthotic Laboratory Matt Rago
K202335 09/04/2020 Ambra ProViewer Dicom Grid, Inc, dba Ambra Health Patrice Nedelec
K192830 09/02/2020 Bright Temporary C&B DMP Dental Industry S.A. Dimitris Prantsidis
K201074 09/03/2020 Delta III Lithotripter Dornier MedTech America, Inc. John Hoffer
K202156 09/10/2020 DIAMOND-5A/6A/8A DRGEM Corporation Ki-Nam Yang
K193212 09/10/2020 DSM Biomedical Dental Bone Graft Plus DSM Biomedical Susan Pileggi
K202394 09/16/2020 EOSedge EOS imaging Bernard Ismael
K193115 09/17/2020 EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun US, Inc. Kruti Shah
K201145 09/10/2020 X-Pac Expandable Lumbar Cage System Expanding Innovations, Inc. Mbithi Muthini
K200948 09/11/2020 Fitbit ECG App Fitbit, Inc. Shruti Rajagopalan
K200530 09/11/2020 AMICUS Separator System Fresenius Kabi AG Kim Forch
K201207 09/18/2020 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K202160 09/01/2020 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System FUJIFILM SonoSite Inc. Anoush Frankian
K192524 09/04/2020 Lumipulse G CA15-3 Fujirebio Diagnostics, Inc. Kristin Maddaloni
K202238 09/04/2020 SIGNA Artist GE Healthcare (Tianjin) Company Limited Qiang Ding
K200708 09/09/2020 Vivid iq GE Medical Systems Ultrasound and Tracey Ortiz
K200852 09/18/2020 EchoPAC Software Only, EchoPAC Plug-In GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K200851 09/09/2020 Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K200469 09/16/2020 PAPAYA 3D Premium & PAPAYA 3D Premium Plus Genoray Co.,Ltd Hyunju Hwang
K200343 09/14/2020 FusionFrame Ring Lock System GLW Medical Innovation Elijah Wreh
K193449 09/11/2020 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) Guangdong Horigen Mother & Baby Products Co., Ltd Jun Deng
K182020 09/17/2020 Portable Electro-Stimulation Therapy Device Guangzhou Longest Science & Technology Co., Ltd. Xiaobing Luo
K192423 09/09/2020 MINT Product Family Hans Biomed Corporation Lucy Choi
K201252 09/09/2020 Spectralis HRA+OCT and variants Heidelberg Engineering GmbH Christoph Schoess
K193664 09/09/2020 SubQKath Catheter and Needle Set HK Surgical Gary Mocnik
DEN190039 09/17/2020 ToothWaveÖ Home Skinovations Ltd. Amit Goren
K192704 09/02/2020 Endofresh Digestive Endoscopy System HuiZhou Xzing Technology Co., Ltd. Yonglin Ni
K202354 09/08/2020 Surgical Mask-Model Number CW01 Hunan Heng Chang Pharmaceutical Co., Ltd. Tao Jingfeng
K201551 09/09/2020 KetoSens BT Blood B-Ketone Monitoring System i-SENS, Inc. Joon Ho Jung
K201570 09/11/2020 PF4 Enhanced assay Immucor GTI Diagnostics, Inc. Allison Stray
K202182 09/02/2020 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Imperative Care Inc. Jake Wolenberg
K193462 09/09/2020 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K200212 09/03/2020 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC. Rick Ferreira
DEN190032 09/17/2020 HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. Carol Marble
K193409 09/09/2020 Vista Rinse, Vista Rinse Plus Inter-Med/Vista Dental Products Alex Johnson
K200503 09/02/2020 ATL Anchors International Life Sciences Tiffini Wittwer
K200827 09/02/2020 LOCATOR R-Tx Ivory Super Holdco, Incp. Marysa Loustalot
K201656 09/15/2020 ARIX Elbow System Jeil Medical Corporation Sejin Ryu
K200027 09/09/2020 Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter Jiangsu Caina Medical Co., Ltd. Jianwei Pan
K201225 09/04/2020 Neodent Implant System - GM Helix Implants 7.0 JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K201470 09/08/2020 Disposable Medical Face Mask JKH USA, LLC Bill Quanqin Dai
K201645 09/15/2020 Massage Compression Boots JKH USA, LLC Bill Quanqin Dai
K201591 09/03/2020 Flat Panel Detector KA Imaging Inc. Samuel To
K201135 09/01/2020 Image1 S CCU, Image1 S 4U Camera Head Karl Storz Endoscopy-America, Inc. Alita McElroy
K201538 09/18/2020 Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine Inc. Angela Batker
K201721 09/04/2020 TruLift Expandable Spacer System Life Spine Inc. Angela Batker
K202007 09/17/2020 LZI Oxycodone III Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K193439 09/04/2020 MEBO Wound Dressing MEBO Life Science Inc. Sidney Hong
K202022 09/18/2020 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) Medacta International SA Stefano Baj
K201673 09/18/2020 SMS Cementless Stem Medacta International SA Stefano Baj
K202176 09/03/2020 Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes Medical Components Inc. (Dba Medcomp) Courtney Nix
K201506 09/11/2020 Talos«-C Cervical Intervertebral Body Fusion System, Talos«-C (HA) Cervical Intervertebral Body Fusion System Meditech Spine, LLC Bruce Dunaway
K201390 09/18/2020 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) Medline Industires, Inc. Adam Ostrower
K201829 09/09/2020 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Jennifer Mason
K201661 09/16/2020 Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set Medos International, SARL Nicole Aeschbacher
K201224 09/18/2020 Electrosurgical Generator and Accessories Medrange Helen Xie
K202328 09/08/2020 CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc. Venkata Sandeep Manne
K201407 09/10/2020 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, INC. Usman Rashid
K201765 09/02/2020 SmartHDM-510 System Mesa Laboratories, Inc. Jamie Louie
K202318 09/14/2020 Marathon Flow Directed Micro Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Elizabeth Campion
K193340 09/11/2020 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System MicroTech Medical, Inc. Dore Mark
K202297 09/11/2020 Aline Ablation Intelligence Mirada Medical Ltd David Clafton
K201854 09/01/2020 CAPOGEN Laser Cap Nature Incredible Inc John Lee
K201769 09/03/2020 Cavetto [MAX] Cervical Cage System NeuroStructures, Inc. Moti Altarac
K202192 09/17/2020 STRUXXURE«-L and STRUXXURE«-A Plate System Nexxt Spine LLC Andy Elsbury
K200430 09/16/2020 Precice« Ankle Salvage System NuVasive Specialized Orthopedics, Inc. Ivanna Lopez
K190798 09/18/2020 LaborViewÖ LV1000 Wireless Electrode System OBMedical Company Mark A. Samuels
K201841 09/06/2020 EyeBOX Oculogica, Inc. Rosina Samadani
K201920 09/01/2020 Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp. Toshiyuki Nakajima
K201013 09/18/2020 Optixon 1-Day Optixon Inc. Oh Jeong Ju
K200516 09/02/2020 OCT-Camera ID 21101A3 OptoMedical Technologies GmbH Julia Behrens
K201664 09/15/2020 FIREBIRD SI Fusion System Orthofix Inc. Jacki Koch
K192653 09/09/2020 Perseus Orthokey Italia S.r.l. Cristiano Paggetti
K200812 09/02/2020 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter Philips Image Guided Therapy Corporation Rand Daoud
K192137 09/11/2020 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K200603 09/20/2020 AAA Model Philips Ultrasound, Inc Hebe Sun
K201665 09/15/2020 Collaboration Live Philips Ultrasound, Inc. Colin S. Jacob
K202216 09/02/2020 EPIQ Series Diagnostic Ultrasound Systems Philips Ultrasound, Inc. Colin S. Jacob
K202286 09/16/2020 Tulsa-Pro System Profound Medical Inc Goldy Singh
K201774 09/16/2020 Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs PT. Medisafe Technologies Sajeev Joseph
K201691 09/17/2020 Single-Use Surgical Mask With Ear Loop Qiqihar Hengxin Medical Supplies, Ltd. Sihui Xiong
K202169 09/02/2020 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.r.l Raffaella Tommasini
K202287 09/18/2020 Ran-Flex-B Bone Marrow Aspiration Needle Ranfac Corporation Eric Kreuz
K201746 09/18/2020 Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited Timothy Bubb
K202153 09/09/2020 Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy LLC Douglas Korhs
K200135 09/10/2020 RGK Daily Range Wheelchairs RGK Wheelchairs, Ltd. Devin McElroy
K202399 09/18/2020 OrthoButton FL Riverpoint Medical Amanda Cole
K202242 09/10/2020 HS Fiber Riverpoint Medical, LLC Edwin Anderson
K202215 09/02/2020 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Rita Hoady
K201909 09/10/2020 RxSight Contact Lens RxSight, Inc. Maureen O'Connell
K201073 09/18/2020 Seaspine WaveForm C Interbody System SeaSpine Orthopedics Corporation Aly Alvarez
K201646 09/14/2020 Shoreline ACS (Anterior Cervical System) SeaSpine Orthopedics Corporation Alicia McArthur
K201369 09/16/2020 AVA (Augmented Vascular Analysis) See-Mode Technologies Pte. Ltd. Sadaf Monajemi
K193655 09/04/2020 MSLS6QF TENS/PMS Device Self Doctor Care, LLC Wei Wei
K192890 09/18/2020 SentEP SentiAR, Inc Berk Tas
K201537 09/04/2020 Protective Face Mask for Medical Use Shandong Shengquan New Material Co., Ltd. Xiumei Zhang
K201731 09/10/2020 Diode Laser Body Sculpture System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K201211 09/03/2020 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K193657 09/12/2020 Disposable Enteral Feeding Syringe with Enfit Connector Shinva Ande Healthcare Apparatus Co., Ltd. Xiaolei Tian
K202014 09/08/2020 Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit Siemens Medical Solutions USA, Inc. Andrew Turner
K192375 09/18/2020 Intellifuse Administration and Intellifuse Blood Administration Sets Smiths Medical ASD, Inc. Wendy Hills
K200862 09/14/2020 Feelix Stethoscope Sonavi Labs, Inc. Ian McLane
DEN200010 09/18/2020 Spineology Interbody Fusion System Spineology, Inc. Andrew Adams
K202197 09/04/2020 Astopad Patient Warming System Stihler Electronic GmbH Jens- Peter Weege
K201450 09/10/2020 Straight T Clear Dental Aligner Straight T, Inc. Minh Trinh
K201900 09/03/2020 3D GraftRasp System SurGenTec Andrew Shoup
K192702 09/18/2020 DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Synthes (USA) Products LLC Jeffrey Krawiec
K201944 09/10/2020 DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Synthes (USA) Products, LLC Prem Pisupati
K201336 09/03/2020 DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm Synthes (USA) Products, LLC Pol Fort Grebol
K201578 09/09/2020 DePuy Synthes Variable Angle Locking Patella Plating System Synthes (USA) Products, LLC Enrico Gindro
K200724 09/01/2020 VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH Friedrich Moritz
K201277 09/02/2020 Oral-B Dry Mouth Oral Rinse The Proctor & Gamble Company Michael A Kaminski
K192111 09/03/2020 Biodegradable Nitrile Examination Powder Free Glove, Green Top Glove SDN BHD Noor Akilah Saidin
K201315 09/11/2020 PERFORM Humeral System û Stem Tornier, Inc. Renee Stoffel
K202227 09/14/2020 ArtusÖ cervical plate system Ulrich GmbH & Co. KG Christoph Ulrich
K200845 09/10/2020 Navigation Module of the Momentum System ulrich medical USA Hans Stover
K202463 09/18/2020 Disposable Surgical Mask Unisources Group LLC Henry Shen
K202187 09/11/2020 FLEX Vessel Prep System VentureMed Group, Inc. Jill Schweiger
K202143 09/11/2020 Dynex Micro Vilex, LLC Joyce Thacker
K200833 09/02/2020 RX-1 Rhythm Express Remote Cardiac Monitoring System VivaQuant Inc. Brian Brockway
K201090 09/09/2020 Structur CAD VOCO GmbH M. TH. Plaumann
K201298 09/16/2020 VX1 Volta Medical Th?ophile Mohr Durdez
K193368 09/18/2020 Smart Correction System WishBone Medical, Inc. Mary Wentorf
K202360 09/16/2020 Ziehm Vision RFD 3D Ziehm Imaging GmbH Stefan Fidler


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