FDA 510(k) Applications Received During October, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K182784 10/01/2018 MUTYH-Associated Polyposis (MAP) 23andMe, Inc. Sarah Rys
K183011 10/31/2018 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics Gregory Kowalczyk
K182782 10/01/2018 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Alcon Laboratories, Inc. Martina Heim
K182902 10/16/2018 Precision1 Alcon Laboratories, Inc. Alicia Plesnarski
K182988 10/29/2018 Afinion HbA1c Dx on Afinion 2 Alere Technologies AS Monica Vallestad
K182808 10/03/2018 Aspida« Anterior Lumbar Plating System Alphatec Spine, Inc. Ruby Zheng
K182845 10/09/2018 minisono Alpinion Medical Systems Co., Ltd. Boyeon CHO
K182992 10/29/2018 BGM014 Blood Glucose Monitoring System Apex Biotechnology Corp. Lisa Liu
K182815 10/03/2018 XVWeb 3D Apteryx, Inc. Mark Gniewek
K182779 10/01/2018 ARK EDDP Assay ARK Diagnostics, Inc. Cherry Mun
K182878 10/15/2018 Integra Salto Total Ankle System Ascension Orthopedics Divya Savant
K182982 10/29/2018 BridalVeil Navigated Instruments Astura Medical Parker Kelch
K182919 10/19/2018 SI-Restore« Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K183013 10/31/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K182790 10/01/2018 Cardio-TriTest v6.5 Cardio-Phoenix Inc. Marc Bisnaire
K183000 10/30/2018 ViperCath XC Peripheral Exchange Catheter Cardiovascular Systems, Inc. Erika Huffman
K182967 10/26/2018 Visor System Cerebrotech Medical Systems, Inc. Dawnel Scott
K182831 10/09/2018 SabreLine and SabreGuard Laser Fibers Coloplast Corp Cori Ragan
K182882 10/15/2018 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control Conmed Corporation Orjada Dervishleri
K182955 10/24/2018 EZStart Interference Screw ConMed Corporation Jeremy Walter
K182980 10/29/2018 Zilver 518 Biliary Stent, Zilver 635 Biliary Stent Cook Ireland Ltd Cathrina McHale
K182772 10/01/2018 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil Covidien Jennie van Diemen
K182868 10/12/2018 INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien llc Samir Ibrahim
K182997 10/30/2018 enlighten III Laser System Cutera, Inc. Julia Brown
K182783 10/01/2018 DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes Elizabeth Jacobs
K182977 10/26/2018 Isolette 8000 Plus Draeger Medical Systems, Inc. Karen Otrupchak
K183012 10/31/2018 vascuCAP Elucid Bioimaging Inc. Andrew Buckler
K182873 10/12/2018 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Ethicon, Inc. Ariell Joiner
K183004 10/30/2018 WEGO-PGA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K183001 10/30/2018 WEGO-PGLA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K182951 10/23/2018 Pristina Serena 3D GE Healthcare Nicole Landreville
K182838 10/09/2018 Geistlich Derma-Gide Geistlich Pharma AG Marco Steiner
K182880 10/15/2018 Halifax Imaging Kit Halifax Biomedical, Inc. Crystal Jones
K183009 10/31/2018 HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES Hemostatix Medical Technologies, LLC Jeff Cobb
K182801 10/02/2018 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation Jennifer Siu
K182809 10/03/2018 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation MaryBeth Carson
K182956 10/24/2018 Puffin Lite Infant Resuscitation System International Biomedical Amy Pieper
K182946 10/23/2018 Invacare TDX SP2-HD with Captain's Seat Invacare Corporation Elijah Wreh
K182900 10/16/2018 3880 MRI Patient Monitoring System Iradimed Corporation Francis X. Casey
K182916 10/18/2018 Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr LeMaitre Vascular John N. Bradsher
K182795 10/01/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. Keith Peck
K182922 10/19/2018 MTS Omadacycline 0.002-32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K182986 10/29/2018 Boston Keratoprosthesis, Type I Lucia Massachusetts Eye and Ear Infirmary d/b/a Boston James Chodosh
K182914 10/18/2018 MC3 Vascular Access Kit 21030 MC3 Incorporated Adam Viitala
K182837 10/09/2018 M.U.S.T. Mini Extension Medacta International SA Stefano Baj
K182812 10/03/2018 Medline Cautery Electrode (SILICONE) Medline Industries, Inc. Matt Clausen
K182928 10/22/2018 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, Inc. Raphael McInnis
K182957 10/24/2018 Heli-FX EndoAnchor System Medtronic Vascular, Inc. Janelle Wong Keller
K182810 10/03/2018 Distal Radius Plating System Miami Device Solutions, LLC Michelle Montesino
K182989 10/29/2018 AURORAÖ Screw System MiRus, LLC Jordan Bauman
K182970 10/26/2018 EUROPAÖ Pedicle Screw System MiRus, LLC Jordan Bauman
K182776 10/01/2018 Neocis Guidance System Neocis Inc. Thomas E. Claiborne
K182958 10/24/2018 1.5T 16ch Breast Coil NeoCoil, LLC Katie Gonzalez
K182907 10/17/2018 SPY Elite Intraoperative Perfusion Assessment System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K182949 10/23/2018 HealixÖ Compression Screw System Nvision Biomedical Technologies, LLC Diana Langham
K182964 10/25/2018 ROSA Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eric DesRosiers
K182898 10/16/2018 TenoTac Soft Tissue Fixation System Paragon 28, Inc Eric Lintula
K182846 10/09/2018 PENTAX Medical EPK-3000 Video Imaging System PENTAX of America, Inc. William Goeller
K183007 10/31/2018 EliA SmDP Immunoassay Phadia AB Carina Magnusson
K182926 10/22/2018 IntelliSpace Radiology Philips Healthcare Informatics, Inc. Paige Gridack
K182973 10/26/2018 DigitalDiagnost C90 Philips Medical Systems DMC GmbH Ming Xiao
K182857 10/10/2018 EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K182781 10/01/2018 PTS Professional Chemistry Kit Polymer Technology Systems, Inc. d/b/a PTS Diagnostics Samuel Engelman
K182855 10/10/2018 ProKnow DS ProKnow LLC Salvadore Gerace
K182805 10/02/2018 RCT800 RAY Co., Ltd Changhwan Lee
K182894 10/15/2018 HM70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K182905 10/16/2018 UniPulse Seaward Group Jim Wallace
K182938 10/23/2018 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K182869 10/12/2018 Fit SA Shofu Dental Corporation Mauro Malzyner
K182983 10/29/2018 iFuse Implant System« SI-BONE, Inc. Roxanne Dubois
K183010 10/31/2018 Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks Smith & Nephew, Inc. Brad Sheals
K182954 10/24/2018 SalvoÖ Spine System Spine Wave, Inc. Amy Noccioli
K182827 10/05/2018 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 STERIS Corporation Marcia L. Benedict
K182931 10/22/2018 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporations Jennifer Nalepka
K182968 10/26/2018 Hoffmann LRF System Stryker GmbH Jackie Perri
K182826 10/05/2018 Ormco Spark Aligner System Sybron Dental Specialties Mey Saied
K182797 10/01/2018 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ?g/mL Thermo Fisher Scientific Cynthia Knapp
K182909 10/17/2018 Roth Net Retriever Product Line United States Endoscopy Group, Inc. Carroll Martin
K182972 10/26/2018 Phoenix Atherectomy System Volcano AtheroMed Inc. Jean Chang
K182895 10/15/2018 Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc Theresa de Prat
K182823 10/04/2018 PRODENSE Bone Graft Substitute Wright Medical Technology, Inc. Alayne Melancon


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