FDA 510(k) Applications Received During October, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K192937 10/18/2019 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company Mary Fretland
K192961 10/22/2019 ADH19 3M Deutschland GmbH Ruediger Franke
K192992 10/25/2019 Suglue 3 3M Deutschland GMBH Desi W. Soegiarto
K192945 10/18/2019 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application 7D Surgical Inc. Daniel Zisind
K193015 10/29/2019 HydroPICC (PICC-142) Access Vascular, Inc Brian Hanley
K193041 10/31/2019 Hemochron Signature Elite Accriva Diagnostics, Inc. Brian James
K192887 10/10/2019 Revitive Medic Plus, Revitive Advanced 2 Actegy, Ltd. Lawrence Brookfield
K193013 10/29/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Karla Schaffner
K192898 10/11/2019 PneumoLiner Advanced Surgical Concepts Edward Hyland
K192938 10/18/2019 InvictusÖ Spinal Fixation System Alphatec Spine, Inc. Cynthia Adams
K192944 10/18/2019 AncestryDNA Factor V Leiden Genetic Health Risk Test Ancestry Genomics, Inc. Raajdeep Venkatesan
K192947 10/18/2019 AncestryDNA Saliva Collection Kit Ancestry Genomics, Inc. Raajdeep Venkatesan
K192864 10/07/2019 UNI*FUSE Infusion System with Cooper Wire Angiodynamics, Inc. Brandon M. Brackett
K192912 10/15/2019 AutoMIStar Apollo Medical Imaging Technology Pty. Ltd. Qing Yang
K192953 10/21/2019 APTOS Threads û Polypropylene Surgical Sutures APTOS, LLC. Nikolai Pirtskhalaichvili
K192846 10/03/2019 Argen Clear Aligner, Argen Clear Aligner Premium Argen Corporation Paul Cascone
K192930 10/17/2019 Dymaxeon Spine System Back 2 Basics Direct, LLC Lou Keppler
K192829 10/02/2019 Demetra BDEM-01 Dermatoscope Barco NV Julie Vandecandelaere
K192948 10/18/2019 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G Bard Peripheral Vascular, Inc. Meghan McKelvey
K193028 10/30/2019 MEDRAD Mark 7 Arterion Injection System Bayer Medical Care Inc. Kelly Frank
K192880 10/09/2019 InferRead Lung CT.AI Beijing Infervision Technology Co.,Ltd. Xiaoyan Fan
K192942 10/18/2019 ALLthread Titanium Suture Anchor Biomet Inc. Saveetha Raghupathi
K192996 10/28/2019 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Biotronik, Inc Jon Brumbaugh
K192958 10/22/2019 TwitchView System Blink Device Company Justin Hulvershorn
K192867 10/07/2019 Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) Bovie Medical Corporation dba Apyx Medical Corporation Topaz Kirlew
K192822 10/01/2019 Benesta Hysteroscope Caldera Medical, Inc. Vicki Gail
K192828 10/02/2019 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Canon Medical Systems Corporation Paul Biggins
K192832 10/02/2019 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Canon Medical Systems Corporation Paul Biggins
K193021 10/30/2019 Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation Paul Biggins
K192923 10/16/2019 Vitrea Software Package Canon Medical Systems Corporation Paul Biggins
K192894 10/11/2019 Vita Flex CR System with LLI Carestream Health, Inc. Duane Gutowski
K192871 10/08/2019 B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention Yon Yu
K192885 10/10/2019 C.T.M. Mobility Scooter HS-268 Chien Ti Enterprise Co., Ltd. Vivian Lo
K192939 10/18/2019 Volumetric Specimen Imager Clarix Imaging Xiao han
K192954 10/21/2019 Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe
K192841 10/03/2019 InPen System Companion Medical, Inc. Jasper Benke
K193042 10/31/2019 Optimized Positioning System (OPS) ReView Corin USA Lucinda Gerber
K192905 10/15/2019 Creo Electrosurgical System with HS1 Hemostasis Accessory Creo Medical Ltd. Leif Geoghegan
K193043 10/31/2019 Critical Alert CommonPath Enterprise Critical Alert John Elms
K192863 10/07/2019 MONDRIAN Lumbar Interbody Fusion Cage System CTL Medical Corporation Sean Suh
K193019 10/29/2019 DANNIK Disposable Monopolar Laparoscopic Instrument Dannik Olga Haberlad
K192973 10/24/2019 densitas densityai Densitas, Inc. Mo Abdolell
K192806 10/01/2019 DENTCA Crown and Bridge Dentca, Inc. Jason Lee
K192855 10/04/2019 DELTA XTEND(TM) Reverse Shoulder System DePuy (Ireland) Ashley Goncalo
K192946 10/18/2019 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K192919 10/15/2019 Pinnacle Duofix HA Acetabular Cup Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K193027 10/30/2019 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French DeRoyal Industries, Inc. Sarah Bennett
K193005 10/28/2019 DIMI RRT System Dialco Medical Inc. Danijela Domljanovic
K192847 10/03/2019 AUTOLIGN Diorco Co., Ltd. Yongkyu Jin
K192830 10/02/2019 Bright Temporary C&B DMP Dental Industry S.A. Dimitris Prantsidis
K192920 10/16/2019 Oragene«òDx DNA Genotek Inc. Austin Udocor
K193017 10/29/2019 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP DRTECH Corporation Shin Dongwook
K193031 10/30/2019 EXPD 4343P, EXPD 3643P DRTECH Corporation Dongwook Shin
K192889 10/10/2019 Neo eemagine Medical Imaging Solutions GmbH Maarten Van De Velde
K192951 10/21/2019 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun Ellipse A/S Ole Kofod
K192842 10/03/2019 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Eurotrol B.V. Elisanne Biemans
K192888 10/10/2019 EzOrtho Ewoo Soft Co., Ltd. Young Seok Kim
K192969 10/23/2019 Ezra Plexo Software Ezra AI Inc. David Girard
K192928 10/17/2019 Optiflux Enexa F500 Dialyzer Fresenius Medical Care Reanal Therapies Group LLC Denise Oppermann
K192932 10/17/2019 FDR D-EVO III flat panel detector system FUJIFILM Corporation Randy Vader
K192918 10/15/2019 Video Laparoscope, Video Processor, Light Source FUJIFILM Corporation Randy Vader
K192956 10/21/2019 Auto Positioning GE Hangwei Medical Systems, Co., Ltd. Yonghui Han
K192917 10/15/2019 ViewPoint 6 GE Medical Systems Ultrasound and Tracey Ortiz
K192819 10/01/2019 OEC Elite GE OEC Medical Systems, Inc. Kenny M Bello
K192922 10/16/2019 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter Gentuity, LLC David Kolstad
K192915 10/15/2019 GMA 2.0 Pedicle Screw System Grafton Medical Alliance James Henry
K193033 10/31/2019 GSI Audera Pro Grason Stadler Brent Nissly
K192851 10/03/2019 OASIS MRI System Hitachi Healthcare Americas Aaron Pierce
K192859 10/04/2019 CareSens S Clear BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K192962 10/22/2019 icobrain-ctp Icometrix NV Dirk Smeets
K192897 10/11/2019 icotec Cervical Cage icotec ag Marina Hess
K193020 10/30/2019 VenaPro Vascular Therapy System Innovamed Health, LLC Luke Zeutzius
K192998 10/28/2019 Reprocessed BRK Transseptal Needle Innovative Health, LLC. Amanda Babcock
K192843 10/03/2019 INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream Innovita (Tangshan) Biological Technology Co., Ltd Leo Lee
K192893 10/11/2019 Straumann Ceramic Healing Abutments Institut Straumann AG Laure Kuhner Borsenberger
K192852 10/03/2019 MRI ECG Patient Cable Ivy Biomedical Systems, Inc. Alejandra Aceves
K192987 10/25/2019 Aina HbA1c Monitoring System 2 Jana Care, Inc Michal Depa
K193022 10/30/2019 Retractable Safety Insulin Syringe Jiangsu Caina Medical Co.,Ltd. Xinyan Ruan
K192911 10/15/2019 Brainlab Compatible K2M Navigation Instruments K2M, Inc. Oonagh Lahiff
K192963 10/23/2019 Kogent Torus Ultrasonic Aspirator Katalyst Surgical, LLC Meryl Koch Wilhelm
K192845 10/03/2019 Sperm Freeze, Sperm Fridge Kitazato Corporation Futoshi Inoue
K192979 10/24/2019 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K192966 10/23/2019 FlowMet Laser Associated Sciences, Inc. Sean White
K192925 10/16/2019 32HL512D LG Electronics Inc. Jinhwan Jun
K193007 10/28/2019 LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module LiNA Medical ApS Jaroslaw Mr?wczynski
K192856 10/04/2019 MT One M&T SRL Fiorenzo Rossi
K192834 10/02/2019 MECTA Sigma Mecta Corporation Robin Nicol
K192906 10/15/2019 Mecta-C Stand Alone Medacta International SA Stefano Baj
K192827 10/02/2019 Quadra-P Medacta International SA Stefano Baj
K192967 10/23/2019 Medacta Shoulder System Medacta International, SA Stefano Baj
K192984 10/25/2019 APTUS Clavicle System Medartis AG Andrea Kiefer-Schweizer
K192891 10/10/2019 Laparoscope Lens Shield Device (LENS) Medeon Biodesign, Inc Tsung-Yu Hsieh
K192807 10/01/2019 Duo-Flow Side x Side Double Lumen Catheter Medical Components Inc. (dba MedComp) Courtney Nix
K192988 10/25/2019 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use Medline Industries, Inc. Jennifer Mason
K192985 10/25/2019 Medline Glide-On 3G Vinyl Examination Gloves Medline Industries, Inc. Stephanie Augsburg
K192820 10/01/2019 SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Matt Clausen
K192804 10/01/2019 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm Medos International SARL Michael Liao
K193011 10/29/2019 CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek USA, Inc. Lee Grant
K192817 10/01/2019 Curian HpSA, Curian Analyzer Meridian Bioscience, Inc. Cathlena Martinez
K192907 10/15/2019 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K192809 10/01/2019 Dental Handpiece Micro-NX Co., Ltd. Sojeong Park
K192943 10/18/2019 CEDIA Heroin Metabolite (6-AM) assay Microgenics Corporation Sharron Penn
K192813 10/01/2019 Plasma IQ Neauvia North America, Inc Misty Williams
K193004 10/28/2019 Monopolar Cord New Deantronics Taiwan Ltd Jane Liu
K192900 10/15/2019 H500 Multi-Sensing Oximetry System Nonin Medical, Inc. Kim E Aves
K193016 10/29/2019 PRECICE Bone Transport System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K193039 10/31/2019 Single Use Balloon Dilator V (with knife) Olympus Medical Systems Corp. Toshiyuki Nakajima
K193026 10/30/2019 Visera Elite II Video System Center, Visera Elite II Endoeye 3D Olympus Medical Systems Corp. Toshiyuki Nakajima
K192941 10/18/2019 HySil Super Fast Impression Materials Osstem Implant Co., Ltd. Jungmin Yoo
K192995 10/25/2019 OsteoRemedies Hip Spacer System OsteoRemedies, LLC Eric Stookey
K192994 10/25/2019 Paragon 28 APEX 3D Total Ankle Replacement System Paragon 28, Inc. Eric Lintula
K192824 10/02/2019 Parcus Knotless AP Suture Anchors Parcus Medical, LLC Paul Vagts
K192964 10/23/2019 Parcus Synd-EZ SS Parcus Medical, LLC Paul Vagts
K193036 10/31/2019 C2 CryoBalloon EndoGrip PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Singh Nanda
K192981 10/24/2019 Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Penumbra, Inc Teri Nguyen
K192833 10/02/2019 Indigo Aspiration System Penumbra, Inc. Teri Nguyen
K192955 10/21/2019 Penumbra LP Coil System Penumbra, Inc. Anush Puvvada
K192875 10/08/2019 Philips Biosensor BX100 Philips Medical Systems Suzanne Goodman
K192914 10/15/2019 Stimuplex Onvision System Philips Medical Systems Nederland B.V. Gert de Vries
K192869 10/07/2019 SherpaPak Lung Preservation System , SherpaPak Liver Transport System Pragonix Technologies Lisa Anderson
K192858 10/04/2019 A1AT Genotyping Test Progenika Biopharma S.A., A Grifols Company Diego Tejedor
K193009 10/28/2019 Promisemed Heel Blood Lancet Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K192990 10/25/2019 Litho Evo Quanta System spa Francesco Dell'Antonio
K192850 10/03/2019 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.r.l. Raffaella Tommasini
K193032 10/31/2019 KY Grosz Liquid RB Health (US) LLC Elizabeth Viguerie
K192982 10/25/2019 KY Grosz UltraGel RB Health (US) LLC Elizabeth Viguerie
K193012 10/29/2019 speX Support Catheter ReFlow Medical Krystal Santiago
K192815 10/01/2019 Elecsys BRAHMS PCT Roche Diagnostics Wes Gerbig
K192926 10/16/2019 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K192903 10/15/2019 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
K192910 10/15/2019 STATClave G4 Chamber Autoclave SciCan Ltd. Teresa Boyce
K193040 10/31/2019 Resorbable Mesh Device SeaSpine Orthopedics Corporation Caryn Sailor
K192936 10/18/2019 Soltus 500 Sedecal., SA. Ma Luisa Gomez de Aguero
K192890 10/10/2019 SentEP SentiAR, Inc Berk Tas
K193001 10/28/2019 Albumin BCP Sentinel CH. SpA Patricia Dupe
K192972 10/24/2019 Patient Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K192924 10/16/2019 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit Siemens Medical Solutions USA Inc. Andrew Turner
K192835 10/02/2019 ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System Siemens Medical Solutions, USA, Inc. Hyunjung Lee
K192883 10/10/2019 Spartan Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K192866 10/07/2019 Chemfort CSTD Simplivia Healthcare Ltd. Itsik Shmueli
K192876 10/08/2019 INTELLIO Tablet Application Smith & Nephew Janice Haselton
K193029 10/30/2019 CONQUEST FN Smith & Nephew, Inc. Thomas Fearnley
K193003 10/28/2019 NemoCast Software Nemotec S.L. Carlos Arias
K192873 10/08/2019 SX-One MicroKnife Sonex Health, Inc. Aaron Keenan
K192838 10/03/2019 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure Spectrum Medical Ltd Colleen Powell
K192993 10/25/2019 SCARLET AL-T Spineart Franck Pennesi
K192952 10/21/2019 Spire Health Remote Patient Monitoring System Spire, Inc. d/b/a Spire Health Joanne Hollenbach
K192929 10/17/2019 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 STERIS Corporation Jennifer Nalepka
K192818 10/01/2019 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System Stryker Corporation Kristi Ashton
K193034 10/31/2019 AXS Infinity LS Plus Long Sheath Stryker Neurovascular Shivani H Patel
K193018 10/29/2019 Surgical Direct Hand-held Laparoscopic Instruments Surgical Direct, Inc. David Murray
K192854 10/04/2019 MammoScreen Therapixel Quentin de Snoeck
K193024 10/30/2019 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL Thermo Fisher Scientific Cynthia Knapp
K193006 10/28/2019 MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system Tonica Elektronik A/S Sanne Barsballe Jessen
K192877 10/08/2019 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K192974 10/24/2019 Tyber Medical Trauma Screw Tyber Medical LLC Mark Schenk
K192975 10/24/2019 Tyber Medical Trauma Screws Tyber Medical LLC Mark Schenk
K192872 10/08/2019 ulrichINJECT CT Motion ulrich GmbH & Co. KG Sven Erdmann
K192810 10/01/2019 Apollo Suture Anchor System Valeris Medical Brendan Thies
K192968 10/23/2019 IDENTIFY Varian Medical Systems, Inc. Peter J Coronado
K192935 10/17/2019 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P DuMontelle
K192991 10/25/2019 Vesco Medical Extension Feeding Set Vesco Medical LLC Chris O'Keefe
K192957 10/21/2019 VivaChek Blood Glucose and B-Ketone Monitoring System Vivachek Biotech (Hangzhou) Co., Ltd Mark Qian
K192886 10/10/2019 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation Jenny Fu
K192908 10/15/2019 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes Wilson-Cook Medical, Inc Tiffanny A. Thomas
K192901 10/15/2019 HealthVCF Zebra Medical Vision Ltd. Flair Bar
K193030 10/30/2019 Avenir Muller Stem, Avenir Cemented Hip Stem Zimmer GmbH Roberto Tommasini
K192940 10/18/2019 CoolTone Zimmer MedizinSysteme GmbH Ute Hauss


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