FDA 510(k) Applications Received During February, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K200496 02/28/2020 Aer X 3B Medical Inc. Yasser Estafanous
K200306 02/06/2020 CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit Abbott (formerly Thoratec Corporation) Bindya Gadhia
K200492 02/28/2020 i-STAT CG4+ Cartridge with the i-STAT 1 System Abbott point of Care, Inc. Susan Tibedo
K200387 02/18/2020 Ace Medical Surgical Instruments Ace Medical Alex Ebner
K200300 02/06/2020 VivAer Stylus Aerin Medical Inc Matthew M Hull
K200361 02/14/2020 Akros Scruture Anchor LisFranc Repair Kit Akros Medical Charles Horrell
K200311 02/06/2020 VersaWrap Tendon Protector Alafair Biosciences Inc Ben Walthall
K200450 02/24/2020 X-Cube 70 Alpinion Medical Systems Co., Ltd. Boyeon CHO
K200449 02/24/2020 X-Cube 90 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K200322 02/10/2020 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K200268 02/03/2020 HaloÖ Single-Loop Snare Kit Argon Medical Devices, Inc. Ana Jimenez-Hughes
K200413 02/19/2020 Symphony Aroa Biosurgery Ltd. Tina O'Brien
K200341 02/11/2020 Arthrex FiberTak Suture Anchor Arthrex Inc. Jessica L. Singelais
K200433 02/21/2020 iBalance UKA Tibial Tray Implant Arthrex Inc. Ivette Galmez
K200352 02/13/2020 Axis Spine Technologies ALIF Axis Spine Technologies Ltd Edwin Lindsay
K200266 02/03/2020 BD Centro Vena Acute Central Line (7 French Dual Lumen) Bard Access Systems, Inc. (Bard has joined BD) Breanna Casados
K200280 02/04/2020 MEDRAD Imaging Bulk Package Transfer Spike Bayer Medical Care Inc. Leslie S O'Nan
K200462 02/25/2020 EtchPro Etching Gel Belport Company, Inc., Gingi-Pak Daniel Wang
K200262 02/03/2020 L100 Go System Bioness Inc. Mercedes Bayani
K200482 02/27/2020 StimRouter Neuromodulation System Bioness Inc. Sageev George
K200359 02/13/2020 NuEra Tight, NuEra Tight EMS Bios s.r.l. Maurizio Bianchi
K200444 02/24/2020 Biomonitor III, Biomonitor IIIm BIOTRONIK, Inc. Jon Brumbaugh
K200483 02/27/2020 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller Boston Scientific Corporation Inderdeep Tiwana
K200257 02/03/2020 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System Boston Scientific Corporation Catherine Sanford
K200435 02/24/2020 Catalyst+, Catalyst+ HD C-Rad Positioning AB Thomas Matzen
K200274 02/04/2020 CariCloud Caristo Diagnostics James Davis
K200313 02/06/2020 VIVO Catheter Precision, Inc. Steve Adler
K200457 02/25/2020 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming CC Wellness LLC Marlent Perez
K200370 02/14/2020 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit Centers For Disease Control And Prevention Yon Yu
K200445 02/24/2020 The C100 Contactless Breathing Monitor Circadia Technologies Ltd. Michal Maslik
K200395 02/18/2020 LOSPA II Knee System (EXULT Knee Replacement System) Corentec Co., Ltd Sungwon Yang
K200267 02/03/2020 LOSPA« ISÖ Spinal Fixation System Corentec Co., Ltd. Sungwon Yang
K200427 02/21/2020 Sonicision Cordless Ultrasonic Dissector Covidien, llc Celso Duran
K200373 02/14/2020 Deltaven Fast Flash Closed I.V. Catheter Systems Delta Med Spa Raschi Olga
K200319 02/07/2020 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable DeRoyal Industries, Inc. Sarah Bennett
K200258 02/03/2020 Edwards eSheath Introducer Set Edwards Lifesciences Vilma Arechiga
K200358 02/13/2020 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula Edwards Lifesciences LLC Anna Califato
K200499 02/28/2020 QuickDraw Venous Cannula Edwards Lifesciences LLC Diem My Nguyen
K200485 02/27/2020 RadiForce RX1270, RadiForce RX1270-AR EIZO Corporation Hiroaki Hashimoto
K200355 02/13/2020 Duranext Abutments Elegant Dental Corp. Gary Fingerman
K200253 02/03/2020 Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector Ethicon Endo-Surgery Emily Nesbitt
K200420 02/20/2020 Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green Ethicon Endo-Surgery, LLC Nathan Anderson
K200337 02/11/2020 FloPatch (FP120) Flosonics Medical (r/a 1929803 Ontario Corp.) Andrew Eibl
K200481 02/27/2020 Andorate Biopsy Valve, Andorate Biopsy Irrigator GA Health Company Limited Cindy Ye
K200495 02/28/2020 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve GA Health Company Limited Cindy Ye
K200479 02/27/2020 AquaPulse Auxiliary Water Connector GA Health Company Limited Cindy Ye
K200388 02/18/2020 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector GA Health Company Limited Cindy Ye
K200494 02/28/2020 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare Joel Kent
K200497 02/28/2020 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K200469 02/26/2020 PAPAYA 3D Premium & PAPAYA 3D Premium Plus Genoray Co.,Ltd Hyunju Hwang
K200343 02/11/2020 FusionFrame Ring Lock System GLW Medical Innovation Elijah Wreh
K200305 02/06/2020 NPseal Guard Medical Inc. Machiel Van der Leest
K200263 02/03/2020 Health Line CT Midline Catheter Health Line International Corporation Aaron G Faulkner
K200498 02/28/2020 SCENARIA View Hitachi Healthcare Americas Aaron Pierce
K200436 02/24/2020 Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit Hologic, Inc. Jill Wyland
K200406 02/19/2020 Evolve Breast Pump Hygeia II Medical Group, Inc. Brett Nakfoor
K200295 02/05/2020 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K200396 02/18/2020 Insight Enhanced DRF Digital Imaging System Imaging Engineering, LLC George Jachode
K200324 02/10/2020 NHancer Rx IMDS Operations B.V. E Schulting
K200265 02/03/2020 Surgical Drills Implant Direct Sybron Manufacturing, LLC Reina Choi
K200424 02/20/2020 Giotto Class (Models - 3000X-YY and 4000X-YY) IMS GIOTTO S.p.A. Antonella Rossi
K200293 02/05/2020 InMode System with vTone Applicator InMode Ltd. Amit Goren
K200385 02/18/2020 CONTINUUM PACS Integrated Ophthalmic Systems, Inc. Matthew Carnevale
K200419 02/20/2020 Kalera Vacuum Aspiration Catheter (K-VAC) Kalera Medical, Inc. Jee Shin
K200390 02/18/2020 V.A.C. DERMATAC Drape KCI USA, Inc Margaret Marsh
K200328 02/10/2020 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K200287 02/05/2020 BP-BT Kiosk LD Technology LLC Albert Maarek
K200464 02/26/2020 LG Pra. L Derma LD Scalp Care LG Electronics, Inc. Eunmi Ji
K200338 02/11/2020 ProLift Lateral Fixated Life Spine Inc. Angela Batker
K200308 02/06/2020 MTS Lefamulin 0.016- 256 ?g/mL Liofilchem s. r. 1. Fabio Brocco
K200277 02/04/2020 Livongo Blood Glucose Monitoring System (BG1000) Livongo Health, Inc. Jacob Gendler
K200501 02/28/2020 ArtiSential Laparoscopic Instrument-Electrodes LivsMed Inc. Dong Wook Lee
K200389 02/18/2020 INOmax DSIR Plus Mallinckrodt Manufacturing LLC David Trueblood
K200353 02/13/2020 ManaFlow ManaMed, Inc Trevor Theriot
K200351 02/12/2020 PlasmaFlight ManaMed, Inc. Trevor Theriot
K200356 02/13/2020 MEDO ARIA Medo.ai Dornoosh Zonoobi
K200456 02/25/2020 Becker External Drainage and Monitoring System Medtronic, Inc. Nancy Hampton
K200283 02/04/2020 Medussa-PL Cage Medyssey USA, Inc. Shawn Kim
K200250 02/03/2020 Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor Megadyne Medical Products, Inc. Sharon Sussex
K200297 02/06/2020 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K200500 02/28/2020 Molekule Air Pro RX Molekule, Inc. Frank Bianco
K200443 02/24/2020 EndoTool IV 1.10 Monarch Medical Technologies, LLC Ann Marie Gaitan
K200348 02/12/2020 Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Neocis Inc. Thomas E. Claiborne
K200441 02/24/2020 UroLift Advanced Tissue Control (ATC) System NeoTract, Inc. Brian Gall
K200455 02/25/2020 Trigger Switch and Cord New Deantronics Taiwan, Ltd. Jane Liu
K200471 02/26/2020 Infrared Thermometer Model Number RN-60A,RN-60B Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K200349 02/12/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K200403 02/19/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K200430 02/21/2020 Precice« Ankle Salvage System NuVasive Specialized Orthopedics, Inc. Ivanna Lopez
K200397 02/18/2020 Single Use Biopsy Forceps FB-456D Olympus Medical Systems Corp. Toshiyuki Nakajima
K200369 02/14/2020 OES Elite Ureteroscopes and Accessories Olympus Winter & Ibe GmbH Stefanie Weber
K200275 02/04/2020 OVision Imaging System Ophthalmic Labs, Inc. Matthew Carnevale
K200254 02/03/2020 Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Optina Diagnostics Jean-Philippe Sylvestre
K200325 02/10/2020 Orbit Subretinal Delivery System Orbit Biomedical Stacey Backlund
K200269 02/04/2020 Sapphire II PRO OrbusNeich Medical Trading Inc. John Pazienza
K200282 02/04/2020 Orfit Aerial Couchtop Orfit Industries NV Eddy Marivoet
K200281 02/04/2020 The Gecko Spinal System Ortho Development Corporation Divya Palan
K200259 02/03/2020 Headless Compression Screw System OsteoCentric Extremities, LLC Todd Evans
K200330 02/10/2020 RC-Prime Root Canal Preparation Cream Pac-Dent, Inc Daniel Wang
K200409 02/19/2020 Pelvital System Pelvital USA, Inc. Dale Wahlstrom
K200279 02/04/2020 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine Phadia AB Carina Magnusson
K200410 02/19/2020 Reconnaissance PV .018 OTW Digital IVUS Catheter Philips Image Guided Therapy Corporation Mary Stanners
K200304 02/06/2020 EPIQ Diagnostic Ultrasound System Philips Ultrasound, Inc. Linda Schulz
K200278 02/04/2020 CytoCore Praxis Medical, LLC John Fisher
K200303 02/06/2020 Reform Pedicle Screw System Precision Spine Micheal C. Dawson
K200459 02/25/2020 pREBOA-PRO Catheter Prytime Medical Devices, Inc. Brian Young
K200477 02/27/2020 Flex Body Speeder Quality Electrodynamics, LLC Eric Yeh
K200438 02/24/2020 MPS 3 Myocardial Protection System Quest Medical, Inc. Tosan Onosode
K200363 02/14/2020 Quidel Triage« TOX Drug Screen, 94600 Quidel Cardiovascular Inc. Rachael S Williamson
K200317 02/07/2020 Support Catheter QXMedical, LLC Fernando Di Caprio
K200487 02/27/2020 RayCare 3.1 RaySearch Laboratories AB (publ) Viktoria Hammarstedt
K200284 02/05/2020 R-Sensor, R-Sensor Remedi Co. Ltd. Jadon Koo
K200480 02/27/2020 DreamStation 2 System, DreamStation 2 Advanced System Respironics, Inc. Andy Zaltwanger
K200417 02/20/2020 RIST Radial Access Catheter RIST Neurovascular, Inc. Marianne Grumwaldt
K200326 02/10/2020 Powder Free Nitrile Examination Glove (Aqua Green) Riverstone Resources SDN BHD Suresh Kumar
K200339 02/11/2020 HS40 Diagnostic Ultrasound System Samsung Medison Co., LTD Scully Kim
K200381 02/18/2020 Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation Alicia McArthur
K200290 02/05/2020 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) SeaSpine Orthopedics Corporation Caryn Sailor
K200354 02/13/2020 Electronic stimulator Shenzhen Dongjilian Electronics Co.,Ltd. Zhang Hong
K200437 02/24/2020 Blood Pressure Monitor Shenzhen Jamr Technology Co., Ltd. Luo Fusheng
K200251 02/03/2020 Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Shi Jufang
K200411 02/19/2020 Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shi Jufang
K200474 02/26/2020 Symbia 6.7 Siemens Medical Solutions USA, Inc. Cynthia Busch
K200367 02/14/2020 Distal Humerus Plating System Skeletal Dynamics, Inc. Ana M. Escagedo
K200392 02/18/2020 REXSIN SM ENG CO., LTD Soon-Gu Lee
K200407 02/19/2020 LEGION Inserts with JRNY Lock Smith & Nephew, Inc. Konrad Wolfmeyer
K200331 02/10/2020 Rapid Acoustic Pulse Device Soliton Inc. Leslie Honda
K200312 02/06/2020 Tryptik Ti Spineart Frank Pennesi
DEN200010 02/19/2020 Spineology Interbody Fusion System Spineology, Inc. Andrew Adams
K200446 02/24/2020 STERIS Patient Warming System STERIS Corporation Gregory Land
K200252 02/03/2020 Getinge Assured MI Steam Migrating Integrator SteriTec Products MFG Co Inc Jonathan Rutigliano
K200310 02/06/2020 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Stryker April Malmborg
K200493 02/28/2020 Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover Stryker Corporation Corinne Larke-Grass
K200398 02/18/2020 AxSOS 3 AF System and AxSOS 3 Ti System Stryker GmbH Paul Nelson
K200431 02/21/2020 3D GraftRasp System SurGenTec Andrew Shoup
K200327 02/10/2020 Evry Synaptive Medical Inc. Maham Ansari
K200467 02/26/2020 Control-IQ Technology Tandem Diabetes Care, Inc. Michael Sarrasin
K200400 02/18/2020 Systane iLux2 Tear Film Innovations, Inc. Neal Hartman
K200272 02/04/2020 Terragene Chemdye Terragene SA Maria Victoria Rocha
K200379 02/18/2020 Super Sheath TOGO MEDIKIT CO., LTD. Daisuke Nagamizu
K200360 02/13/2020 TrackX Track X Technology, LLC David Skwerer
K200314 02/06/2020 Capere Thrombectomy System Vascular Medcure, Inc. Jeffrey P DuMontelle
K200285 02/05/2020 VenaOne Vena Group, LLC Kasey Vukson
K200418 02/20/2020 VIVIX-S VW Vieworks Co., Ltd. Jordin Kim
K200468 02/26/2020 V30 system, V20 system, V10 system, V-FC Handpiece Viora Ltd. Simona Forman Krant
K200294 02/05/2020 GrandioSO Light Flow VOCO GmbH M Th Plaumann
K200383 02/18/2020 Wiggins Medical Surgical Instruments Wiggins Medical Alex Ebner
K200453 02/24/2020 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC YTY Industry (Manjung) Sdn Bhd Punitha Samy
K200315 02/07/2020 Ziostation2 Ziosoft, Inc. Tsuyoshi Nagata


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