FDA 510(k) Applications Received During June, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K191534 06/10/2019 ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. Angela Drysdale
K191595 06/17/2019 ARCHITECT STAT High Sensitivity Troponin-I Abbott Laboratories Diagnostics Division Judi Wallach
K191598 06/17/2019 AOS ES Retrograde Femoral Nail Advanced Orthopaedic Solutions, Inc. Elaine Nguyen
K191623 06/18/2019 ScanX Touch/ScanX Duo Touch Air Techniques, Inc. Samir Ghevariya
K191723 06/27/2019 ATEC IOM Accessory Instruments Alphatec Spine, Inc. Ruby Zheng
K191460 06/03/2019 PWD Platform Wound Dressing 3ö x 5ö Oblong Applied Tissue Technologies LLC Michael Broomhead
K191484 06/04/2019 Renuvion/J-Plasma Precise Handpiece Apyx Medical Corporation(formerly Bovie Medical Corporation) Topaz Kirlew
K191714 06/26/2019 ASAHI Neurovascular Guide Wire CHIKAI X 014 soft Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K191537 06/10/2019 eCarbon IBDs Back 2 Basics Direct, LLC Scot Miller
K191471 06/03/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Brit Baird
K191494 06/05/2019 FacilisÖ Spinal System Baui Biotech Co., Ltd. Herman Jhan
K191513 06/07/2019 Altapore Shape Baxter Healthcare Corporation Phillip Romei
K191546 06/12/2019 Epicardial Access System Baylis Medical Company Inc. May Tsai
K191459 06/03/2019 JuggerStitch Meniscal Repair Device Biomet Inc. Kyle Ponce
K191587 06/14/2019 L360 Thigh System Bioness Inc. Mercedes Bayani
K191660 06/21/2019 CARTO 3 EP Navigation System, Version 7.1 and Accessories Biosense Webster, Inc. Phuong Chau
K191469 06/03/2019 Biotronik Stylets Biotronik, Inc Jon Brumbaugh
K191609 06/17/2019 Tria Soft Ureteral Stent Boston Scientific Corporation Justin Kapitan
K191542 06/11/2019 Apyx Plasma/RF Handpiece Bovie Medical Corporation dba Apyx Medical Corporation Topaz Kirlew
K191718 06/26/2019 Buhlmann fCAL turbo and CALEX Cap BUHLMANN Laboratories AG Laura Zurbrugg
K191685 06/24/2019 PicoWay Laser System Candela Corporation Brenda Geary
K191663 06/21/2019 Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation Paul Biggins
K191467 06/03/2019 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 Canon Medical Systems Corporation Paul Biggins
K191582 06/14/2019 Cartesion Prime Canon Medical Systems Corporation Paul Biggins
K191662 06/21/2019 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation Paul Biggins
K191672 06/24/2019 NuFACE Mini Device Carol Cole Company dba NuFACE Nadia Vazirzadeh Miller
K191621 06/18/2019 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan ChoiceSpine, LLC Kim Finch
K191733 06/28/2019 The ZIP Accessory Shuttle for PleuraFlow System ClearFlow, Inc. Dov Gal
K191668 06/21/2019 Infrared Forehead Thermometer (Model IR-FT) Comper Chuangxiang (Beijing) Technology Co., Ltd. Han Du
K191485 06/04/2019 Deflectable Brush Biopsy Set Cook Incorporated Irasema Rivera
K191601 06/17/2019 Valleylab FT10 Electrosurgical Platform Covidien Jennie van Diemen
K191616 06/18/2019 Orthophos S Dentsply Sirona Karl Nittinger
K191589 06/14/2019 Calprest, EasyCal Eurospital S.p.A. Chiara Pelillo
K191592 06/14/2019 CalprestNG, EasyCal Eurospital S.p.A. Chiara Pelillo
K191561 06/13/2019 Exactech Equinoxe Humeral Augmented Trays Exactech, Inc Shing Jen Tai
K191545 06/11/2019 Exogenesis Hernia Mesh Exogenesis Corporation Joseph Khoury
K191577 06/14/2019 Willow Wearable Breast Pump 2.0 Exploramed NC7, Inc. Steve Holmes
K191554 06/12/2019 LightWalker Laser System Family Fotona d.o.o. Lina Rupnik
K191495 06/05/2019 Biopsy Positioner FUJIFILM Corporation Randy Vader
K191544 06/11/2019 Synapse 3D Blood Flow Analysis Fujifilm Corporation Randy Vader
K191699 06/25/2019 Discovery XR656 HD with VolumeRad GE Hualun Medical Systems Co., Ltd Chris Paulik
K191593 06/14/2019 Digital Automatic Blood Pressure Monitor MD36 Series Grandway Technology (Shenzhen) Limited Patrick Chow
K191552 06/12/2019 GM501 Mineral Oil Hamilton Thorne Inc. Donald Fournier
K191633 06/19/2019 Infyna Chic Hollister Incorporated Michelle Schiltz-Taing
K191615 06/18/2019 Huvitz Imaging System Huvitz Co., Ltd. Hyung Min Heo
K191510 06/06/2019 Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae Hycor Biomedical Kaitlyn Weinkauf
K191530 06/10/2019 StoneChecker Imaging Biometrics, LLC Timothy Dondlinger
K191569 06/13/2019 Implantcast ic-Bipolar Head System Implantcast, GmbH Juliiane Hoppner
K191535 06/10/2019 CoLink« Mini Plating System In2Bones USA, LLC Christine Scifert
K191710 06/26/2019 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordon
K191641 06/19/2019 AFFINITY û Variable Angle Distal Radius System, AFFINITY û Variable Angle Distal Radius Plates, AFFINITY û Variable Angle Distal Radius Screws Industrias Medicas Sampedro S.A.S Liliana Zuluaga-Idarraga
K191659 06/21/2019 Instylla Delivery Kit Instylla, Inc. Amita Smith
K191731 06/28/2019 Instylla Microcatheter Instylla, Inc. Amita Shah
K191679 06/24/2019 Omnipod DASH Insulin Management System with interoperable technology Insulet Corporation Julie Perkins
K191684 06/24/2019 MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System Integra Lifesciences Corporation Omayra Ramirez
K191594 06/17/2019 Nuvis Battery Arthroscope Integrated Endoscopy, Inc. Albert Rego
K191507 06/06/2019 Intellijoint« Navigation System Intellijoint Surgical Inc. Breanne Cuddington
K191736 06/28/2019 da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 Intuitive Surgical Vishal Kanani
K191629 06/19/2019 faceLITE iSMART Marketing Svcs Ltd Susan D'Arcy
K191490 06/05/2019 Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K191548 06/12/2019 Nexus Universal Self-Cure Kerr Corporation Ardrena Jackson
K191523 06/10/2019 Visalys Restorative Primer Kettenbach GmbH & Co. KG Katja Simon
K191524 06/10/2019 Visalys Tooth Primer Kettenbach GmbH & Co. KG Katja Simon
K191645 06/19/2019 SKR 4000 Konica Minolta, Inc. Tsutomu Fukui
K191575 06/14/2019 ARx Spinal System Life Spine Inc. Angela Batker
K191636 06/19/2019 APTUS Foot System Medartis AG Andrea Schweizer
K191653 06/20/2019 Freestyle Flex Medela AG Judith Bernardo
K191483 06/04/2019 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures Medos International SARL Ashley Goncalo
K191526 06/10/2019 Cardioblate CryoFlex Surgical Ablation System Medtronic, Inc. Choua Thao
K191596 06/17/2019 Arcadia Balloon Catheter Merit Medical Systems, Inc. Shamsa Karimi
K191608 06/17/2019 Impress Angiographic Catheter Merit Medical Systems, Inc. Luke Meidell
K191496 06/05/2019 TDS Standard Solution Mesa Laboratories, Inc. Jamie Louie
K191632 06/19/2019 PROFEMUR TL2 Stems MicroPort Orthopedics Inc. Sneh Pingle
K191605 06/17/2019 Neocis Guidance System (NGS) Neocis Inc. Thomas E. Claiborne
K191599 06/17/2019 NICO Myriad NOVUS NICO Corporation Sean Spence
K191475 06/04/2019 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate Nobel Biocare AB Charlemagne Chua
K191626 06/18/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation Cesidio Tempesta
K191553 06/12/2019 NuVaisve« Reline« Cervical System NuVasive, Incorporated Michelle Cheung
K191500 06/06/2019 NuVasive« ACP System NuVasive, Incorporated Jessica Silverman
K191505 06/06/2019 Rezum System NxThera (A Boston Scientific Company) Justin Kapitan
K191713 06/26/2019 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly) Omega Medical Imaging, LLC John Newman
K191687 06/24/2019 pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire phenox Limited Gary Brogan
K191503 06/06/2019 MobileRay Pulse SE Digital Imaging System Portavision Medical LLC Terry Ancar
K191521 06/07/2019 Radiance 330 Proton Beam Therapy System ProTom International Holding Corporation Stephen L. Spotts
K191664 06/21/2019 SelectFlex 072 Neurovascular Access System Q'Apel Medical Ken Peartree
K191504 06/06/2019 PowerDR Radiology Information Systems, Inc. Chen-Tai Ma
K191516 06/07/2019 Ali Interbody Fusion System Raed M. Ali, MD., Inc. Raed Ali
K191547 06/12/2019 ReliefBand ReliefBand Technologies LLC Barbara Whitman
K191729 06/27/2019 Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System Roche Molecular Systems, Inc. Kaitlyn Hameister
K191648 06/20/2019 Mariner MIS Pedicle Screw System; SeaSpine Navigation System SeaSpine Orthopedics Corporation Alicia McArthur
K191610 06/17/2019 RTapp SegAna, LLC Rodney Bosley
K191518 06/07/2019 CO2 Laser System Shenzhen GSD Tech Co., Ltd Jiancheng Zhang
K191499 06/06/2019 MAGLUMI 2000 25-OH Vitamin D Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K191531 06/10/2019 Sure-Fine Insulin Syringes Shina Med Corporation Park Sung-soon
K191533 06/10/2019 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG Siemens Healthcare Diagnostics Inc. Paul DaSilva
K191578 06/14/2019 ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control Siemens Healthcare Diagnostics Inc. Matthew Gee
K191468 06/03/2019 syngo.CT Dual Energy Siemens Medical Solutions, USA, Inc Cynthia Busch
K191576 06/14/2019 Mercury« Spinal System, Overwatch« Spinal System Spinal Elements, Inc Julie Lamothe
K191726 06/27/2019 mont blanc & mont blanc MIS Spinal Systems Spineway SA Heloise Macaire
K191688 06/24/2019 SubtleMR Subtle Medical, Inc. Ajit Shankaranarayanan
K191732 06/28/2019 Sutter RaVoR Bipolar Electrodes Sutter Medizintechnik GmbH Ulrike Zeissler
K191617 06/18/2019 Syntec Tibial Nail System Syntec Scientific Corporation Kavin Chu
K191585 06/14/2019 iNtuition-Structural Heart Module TeraRecon Inc. Megha Jain
K191465 06/03/2019 Human IgM Kit for use on SPAPlus The Binding Site Group Ltd. Natasha Verhaak
K191635 06/19/2019 Optilite IgM Kit The Binding Site Group Ltd. Natasha Verhaak
K191557 06/12/2019 CentriMag Acute Circulatory Support System Thoratec Corporation (now part of Abbott) Lori Dondiego
K191565 06/13/2019 Endoskeleton TCS Interbody Fusion Device Titan Spine, Inc Kelly McDonnell
K191711 06/26/2019 ORTHOLOCÖ SPS Shoulder Plating System Tornier Inc. Renee Stoffel
K191482 06/04/2019 Senhance Surgical System TransEnterix Inc. Kaitlyn Alexander
K191480 06/04/2019 Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) Trigg Laboratories, Inc. D/B/A Wet International Louie Goryoka
K191559 06/13/2019 AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM United States Endoscopy Group, Inc Carroll Martin
K191580 06/14/2019 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device Varian Medical Systems, Inc. Peter J. Coronado
K191560 06/13/2019 Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter Vascular Solutions LLC Beka Vite
K191541 06/11/2019 Vave Personal Ultrasound System Vave Health, Inc. Joseph Ko
K191602 06/17/2019 APA Oxy Blade Venner Medical (Singapore) Pte Ltd Adrian P. Waterton
K191493 06/05/2019 Ventripoint Medical System Plus (VMS+) 3.0 Ventripoint Diagnostics, Ltd. Desmond Hirson
K191528 06/10/2019 Venus Legacy Pro Device Venus Concept USA Inc. Yoni Iger
K191676 06/24/2019 Intra.Ox 2.0 Handheld Tissue Oximeter ViOptix, Inc. Scott Coleridge
K191579 06/14/2019 Voyant System Viseon, Inc. Cora Sim
K191611 06/17/2019 Diode Laser Therapy Systems Wingderm Electro-Optics Ltd. Juan Zhou
K191619 06/18/2019 TurboTemp EZ Zest Anchors, LLC Marysa E. Loustalot
K191625 06/18/2019 Persona Revision Knee System Zimmer Inc. Nicole Meredith


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