FDA 510(k) Applications Received During October, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K173318 10/20/2017 Rapid HB, Rapid LB, Rapid MB 3M Deutschland GmbH Ruediger Franke
K173294 10/16/2017 Magnesium Abbott Laboratories Kimberly Senseman
K173310 10/18/2017 SmartTouch Adherium (NZ) Ltd Chris Mander
K173223 10/03/2017 ologen Collagen Matrix Aeon Astron Europe B.V. Horng Ji Lai
K173271 10/12/2017 Aesculap Slim Clip Applier Forceps Aesculap, Inc. Paul Amudala
K173225 10/03/2017 Interlude and private label Unscented 3-piece compact applicator tampon ALBAAD fem Shlomo Helvits
K173303 10/18/2017 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) Alfa Scientific Designs, Inc Naishu Wang
K173212 10/02/2017 Instant-view-PLUS immunochemical Fecal Occult Blood Test Alfa Scientific Designs, Inc. Wen Hua Fan
DEN170086 10/23/2017 TrueTear Intranasal Tear Neurostimulator Allergan Nooshin Azizi
K173359 10/26/2017 Fractional CO2 Surgical Laser System AMI Inc. Hae Youn Lee
K173319 10/20/2017 KaVo NOMAD Pro 2 Handheld X-ray System Aribex Erika Martin
K173376 10/30/2017 ASI Evolution Arlington Scientific, Inc. (ASI) David Binks
K173240 10/05/2017 Arthrex PushLock Arthrex Inc. David L. Rogers
K173277 10/13/2017 ASAHI PTCA Guide Wire ASAHI SION black Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K173324 10/20/2017 ALTA Anterior Cervical Interbody Spacer Astura Medical Thomas Purcell
K173203 10/02/2017 Athena GTX Device Management Suite (ADMS) Software Athena GTX Sean Mahoney
K173242 10/06/2017 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) Aziyo Biologics, Inc. Wendy Perreault
K173380 10/30/2017 b-ONE« Total Hip System b-One Ortho Corp. Clark Hutton
K173361 10/26/2017 IV Administration Set B.Braun Medical Inc. Nancy Skocypec
K173257 10/10/2017 BTI Dental Implant System UnicCa B.T.I. Biotechnology Institute, S.L. Fernanda O Ros
K173381 10/30/2017 Nexxis OR Barco n.v. Eric Caus
K173365 10/26/2017 Bausch + Lomb Boston Scleral Lens Case Bausch & Lomb Incorporated Nancy Fehrman
K173354 10/25/2017 BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. Henry Boland
K173252 10/10/2017 BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) Becton, Dickinson, and Company Laura Stewart
K173374 10/27/2017 TSV BellaTek Encode Healing Abutments Biomet 3i Nichole OÆNeil
K173278 10/13/2017 ToggleLoc System Biomet Inc. Kyle Ponce
K173248 10/10/2017 CARDIOSKIN Bioserenity SAS Quang Tran
K173372 10/27/2017 ExactechGPS Total Shoulder Application Blue Ortho Anthony Boyer
K173400 10/31/2017 ORISE Tissue Retractor System Boston Scientific Thomas Hirte
K173251 10/10/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation Lindsay Forys
K173284 10/16/2017 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K173371 10/27/2017 VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc. Todd Otani
K173259 10/10/2017 Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories Case Medical, Inc Tania Lupu
K173274 10/12/2017 Ceevra Reveal 2.0 Ceevra, Inc. Russ Yoshinaka
K173347 10/25/2017 STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX Centinel Spine, Inc. Jessica Staub
K173263 10/11/2017 Xpert Carba-R Cepheid Yi-Ping Lin
K173398 10/31/2017 Xpert Xpress Strep A Cepheid Yi-Ping Lin
K173215 10/02/2017 Choice Spine LaminoplastyÖ Fixation System Choice Spine, LP Kim Finch
K173192 10/02/2017 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit Codman & Shurtleff, Inc Megan Palumbo
K173352 10/25/2017 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Concentric Medical, Inc. Rhoda M. Santos
K173289 10/16/2017 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter Cook Incorporated David E. Chadwick
K173355 10/25/2017 Gastric Sizing Balloon Catheter Cook Incorporated Colin Jacobs
K173288 10/16/2017 CorPath GRX System Corindus, Inc. Robert Lavado
K173281 10/16/2017 LigaSure Exact Dissector, Nano-coated Covidien Celso Duran
K173270 10/12/2017 Tri-Staple 2.0 Reinforced Reload Covidien Rebecca Magnanimo
K173244 10/06/2017 superDimension Navigation System V7.2 Covidien LLC Kristi Fox
K173199 10/02/2017 PicoSure Workstation Cynosure, Inc Avinash Purohit
K173335 10/23/2017 Gazelle PTFE and Suture Delivery Device Dura Tap LLC Ann R. Lee
K173234 10/05/2017 Swiss LithoClast Trilogy E.M.S Electro Medical Systems SA Sonia Callegaro
K173399 10/31/2017 Endophys Pressure Sensing Sheath Kit- 8F Endophys Holdings, LLC Phillip Purdy
K173291 10/16/2017 6440 Ultrasound System Esaote S.p.A Massimo Polignano
K173315 10/19/2017 SupaChair Powered Wheelchair Eurogreen International Inc. David Hsieh
K173313 10/19/2017 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP Eurogreen International Inc. David Hsieh
K173186 10/02/2017 S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D Everyway Medical Instruments Co., Ltd. Paul Hung
K173375 10/27/2017 Anterior Cervical Plate System Evolution Spine, LLC Douglas Davis
K173388 10/30/2017 Exactech Equinoxe Stemless Shoulder Exactech Inc Thomas McNamara
K173309 10/18/2017 Faxitron VisionCT Faxitron Bioptics Llc Douglas C. Wiegman
K173193 10/02/2017 F&P SleepStyle Fisher & Paykel Healthcare Ltd Jayanti Karandikar
K173363 10/26/2017 Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173226 10/03/2017 CardiMax Electrocardiograph Fukuda Denshi USA, Inc. Doug Blakely
K173287 10/16/2017 Elite HV Radial Galt Medical Corp. David Derrick
K173341 10/24/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Tracey Ortiz
K173395 10/30/2017 MECALL CLISIS SYSTEMS, Discovery RF180 General Medical Merate S.P.A Luca Bianchessi
K173229 10/04/2017 Preview Digital Pregnancy Test Guangzhou Wondfo Biotech Co., Ltd. Bin Chen
K173312 10/19/2017 ProBx Software Harmonus Inc. Nicole Mauro
K173327 10/20/2017 DIP/U.S. Urine Analysis Test System Healthy.io Ltd Ron Zohar
K173196 10/02/2017 SUNTOUCH Dental Dressing Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang
K173201 10/02/2017 UNITY Sacroiliac Joint Fixation System Huvexel Co., Ltd Sung Hee-Lee
K173273 10/12/2017 Aquarius 8600 1417WCI; Aquarius 8600 1717WCI Imaging Dynamics Company Ltd. Nicole Wherry
K173262 10/11/2017 Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, Llc. Amy Stoklas-Oakes
K173379 10/30/2017 Straumann Variobase for Crown AS Institut Straumann AG Gordon Dodds
K173403 10/31/2017 GEM Premier 5000 Instrumentation Laboratory Co. Carol Marble
K173337 10/23/2017 Intuitive Surgical EndoWrist Vessel Sealer Extend Intuitive Surgical, Inc. Crystal Ong
K173228 10/04/2017 U-MED Powder Free Polyethylene Examination Gloves,Blue Color Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. Chen Ye
K173340 10/23/2017 Yikang Latex Foley Catheter Jiangxi Yikang Medical Instrument Group Co., LTD. Nicholas Su
K173329 10/23/2017 jFit Surgical Planner JointVue LLC Mohamed R. Mahfouz
K173269 10/12/2017 KATOR Suture Anchor KATOR LLC Robert Hoy
K173362 10/26/2017 DSM Biomedical Calcium Phosphate Cement Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K173320 10/20/2017 KLS Martin L1 MMF System KLS Martin LP Jennifer Damato
K173323 10/20/2017 AnastoClip GC Closure System LeMaitre Vascular, Inc. Xiang Zhang
K173346 10/25/2017 LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. Keith Peck
K173286 10/16/2017 Cannulated Screw Internal Fixation System Life Spine Inc. Randy Lewis
K173307 10/18/2017 Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ?g/mL Liofilchem s. r. l. Fabio Brocco
K173304 10/18/2017 Finessis Intense Polyisoprene Surgical Glove Lucenxia Prescience Ag Robert Hill
K173386 10/30/2017 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs Lucenxia Prescience AG Robert Hill
K173317 10/19/2017 DiLumen C2; DiLumen Tool Mount Lumendi, LLC Dennis Daniels
K173405 10/31/2017 DiLumen Endolumenal Interventional Scissors (DiLumen Is) Lumendi, LLC Dennis Daniels
K173267 10/11/2017 MasterLoc Stem: Lateralized Plus Medacta International SA Stefano Baj
K173360 10/26/2017 Athena 190 Medical Rehab Products, LLC Brad Evans
K173348 10/25/2017 0.9% Sodium Chloride Injection, USP Medline Industries, Inc. Matt Clausen
K173276 10/12/2017 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Medline Industries, Inc. Claire Pigman
K173249 10/10/2017 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K173338 10/23/2017 Navigated INFINITYÖ Instruments Medtronic Sofamor Danek USA, Inc. Tejas Patel
K173183 10/02/2017 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation Minoti Patel
K173195 10/02/2017 DRI Hydrocodone Assay Microgenics Corporation Minoti Patel
K173385 10/30/2017 Graft Delivery, DePuy Synthes Micromedics, Inc. (d/b/a Nordson MEDICAL) Kristi Brezinka
K173330 10/23/2017 PanNAT STEC Test Micronics, Inc Karen Hedine
K173200 10/02/2017 SOFIA Plus Aspiration Catheter MicroVention, Inc. Naomi Gong
K173326 10/20/2017 MIS CONNECT Conical Connection Abutment MIS Implants Technologies LTD. Noa Ofer
K173305 10/18/2017 NeuroBlate System Monteris Medical, David H. Mueller
K173392 10/30/2017 Pure-Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K173290 10/16/2017 DuoFLEX Coil Suite MR Instruments, Inc Leon Ricord
K173279 10/13/2017 RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder MYCO Medical Supplies, Inc. Sanjiv Kumar
K173366 10/26/2017 NicoletOne Natus Neurology Incorporated Shane T. Sawall
K173402 10/31/2017 Neocis Guidance System (NGS) with Chairside Splint Neocis Inc Alon Mozes
K173377 10/30/2017 3.0T 16ch Breast Coil NeoCoil, LLC Michael Leigh
K173214 10/02/2017 NES Reprocessed RF Stylet (RFS) Northeast Scientific, Inc. (NES) Matthew Farley
K173236 10/05/2017 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K173314 10/19/2017 LessRay System NuVasive, Incorporated Manthan J. Damani
K173205 10/02/2017 Equinox Advantage O-Two Medical Technologies Inc. David Zhang
K173390 10/30/2017 hipEOS oneFIT Medical Camille Vernay
K173197 10/02/2017 Reusable NIBP Cuff Orantech Inc. Yunxi Xiong
K173247 10/06/2017 Surgical Planning Software version 1.1 Ortho Kinematics, Inc Adam Dietz
K173255 10/10/2017 Talon DistalFix Humeral Nail Orthopedic Designs North America, Inc. Robin Wilson
K173391 10/30/2017 OsteoMed QuickFix Hybrid MMF Sterilization Tray OsteoMed LLC Jessica M. Ruperto
K173187 10/02/2017 MobileDiagnost M50 Philips India Limited Nidhi Bathwal
K173356 10/25/2017 Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K173241 10/06/2017 MED-TAB PLUM Medical Solutions GmbH Arpad Bischof
K173189 10/02/2017 Lumfuse TP Precifit Medical Ltd Zhen Yu (Eric) Wu
K173258 10/10/2017 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Pt. Medisafe Technologies Deepak Bang
K173188 10/02/2017 The Graft Natural Bone Substitute Purgo Biologics Inc. Hana Jung
K173250 10/10/2017 Solana GBS Assay Quidel Corporation Ronald H. Lollar
K173283 10/16/2017 Reliance Lumbar IBF System Reliance Medical Systems, LLC Bret M. Berry
K173233 10/05/2017 ReliefBand 1.5 ReliefBand Technologies Dave Hartman
K173358 10/25/2017 ARTAS System Restoration Robotics, Inc. Raymond Lee
K173389 10/30/2017 Rex Medical Aspiration Pump Rex Medical, L.P. Erich Bressler
K173204 10/02/2017 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
K173235 10/05/2017 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile Scientia Vascular LLC David Sabodski
K173285 10/16/2017 JOULE SYSTEM Sciton, Inc Jay M. Patel
K173260 10/10/2017 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e?POD System SeaSpine Orthopedics Corporation Gina Flores
K173334 10/23/2017 SeaSpine Spinous Process System SeaSpine Orthopedics Corporation Gina Flores
K173299 10/17/2017 DRAGON X SPSL4HC, DRAGON X SPSL8HC Sedecal SA MaLuisa Gomez de Aguero
K173206 10/02/2017 SEKURE HbA1c Assay Sekisui Diagnostics PEI Inc. Penny White
K173202 10/02/2017 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set Sekisui Medical Co., Ltd. Kazunori Saito
K173368 10/26/2017 Reusable & Disposable SpO2 Sensors Shenzhen Coreray Technology, Ltd. Simon Fan
K173369 10/27/2017 DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Jean Lei
K173207 10/02/2017 SIC invent Dental Implant Systems SIC invent AG Cretia Arlene McNett
K173378 10/30/2017 syngo«.via protoNeo (Version VA20) Siemens Healthcare GmbH Abhineet Johri
K173332 10/23/2017 OMNI Surgical System Sight Sciences, Inc. Anne-Marie Ripley
K173293 10/16/2017 EVOS Small Fragment Upper Extremity Plates Smith & Nephew, Inc. Samantha Staubach
K173331 10/23/2017 JOURNEY II XR Knee Instruments Smith & Nephew, Inc. Shereen Bienz
K173384 10/30/2017 BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube Smiths Medical ADS, Inc. Donna M. Semlak
K173343 10/24/2017 Zygomatic Implant System Southern Implants (Pty) Ltd Lauranda G. Breytenbach
K173224 10/03/2017 SPIN-SWI SpinTech, Inc. Kay Fuller
K173232 10/04/2017 myMerlin(TM) Mobile Application Model APP1001 St. Jude Medical Jennifer Dunham
K173256 10/10/2017 System 1 endo Liquid Chemical Sterilant Processing System Steris Corporation Marcia L Benedict
K173237 10/05/2017 Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist Syendgen, Inc. Shenda Baker
K173272 10/12/2017 Ergonomic Handle Symmetry Surgical Inc. Christopher Smith
K173301 10/17/2017 BioSphere MIS Putty (BioSphere MIS) Synergy Biomedical, Llc Mark Borden
K173345 10/24/2017 TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System TaiDoc Technology Corporation Sheena Song
K173219 10/03/2017 CAMPYLOBACTER CHEK Techlab, Inc. Donna T. Link
K173217 10/03/2017 CAMPYLOBACTER QUIK CHEK Techlab, Inc. Donna T. Link
K173321 10/20/2017 StimuQuik 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik 21G x Teleflex Medical Kristen Bisanz
K173280 10/16/2017 Neonatal ConchaSmart Breathing Circuits Teleflex Medical, Inc Brian Gall
K173209 10/02/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL Thermo Fisher Scientific Cynthia Knapp
K173275 10/12/2017 OMNICHROMA Tokuyama Dental Corporation Keith A. Barritt
K173382 10/30/2017 Vantage Galan 3T, V4.6 Toshiba Medical Systems Corporation Paul Biggins
K173349 10/25/2017 Operio Toul Meditech AB Tomas Hansson
K173316 10/19/2017 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device TransMed7, LLC James Vetter
K173367 10/26/2017 MC 300* Nebulizer Trudell Medical International Marianne Tanton
K173198 10/02/2017 Facet Screw Fixation System U&i Corporation Yeon-Jung Choi
K173266 10/11/2017 Octane aspiration system Vascular Solutions Inc. Becky Astrup
K173300 10/17/2017 ViaTherm BOOST ViaTherm Therapeutics, Llc. Michael J. Thomas
K173264 10/11/2017 EmbryoScope+ Vitrolife A/S Belinda Dueholm
K173333 10/23/2017 GORE ENFORM Biomaterial W.L. Gore & Associates, Inc. Barbara L Smith
K173311 10/18/2017 ARTHRO-Pump PA304 W.O.M. World of Medicine GmbH Soeren Markworth
K173246 10/06/2017 ANEROID SPHYGMOMANOMETER Wenzhou Bokang Instruments Co., Ltd Youhua Xiang
K173265 10/11/2017 UltraVision 2 Diagnostic Ultrasound System WinProbe Corporation Guy Scott
K173306 10/18/2017 EZ Plate Zavation Medical Products Llc Matt Jones


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