510(k) Report

Devices descending from K012105

149 later devices reach Polyvac Surgical Instrument Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242023Microdent Sterilization CassetteImplant Microdent System S.L.U.20250—
+1K203198KARL STORZ Metal Sterilization TraysKarl Storz Endoscopy America, Inc.202111
+1K203572Karl Storz Radel Sterilization TraysKarl Storz Endoscopy America, Inc.202101
+1K201945KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc.202101
+1K162063Steri-Cassette and Steri-Cage Sterilization Packaging SystemSybron Dental Specialties20170—
+1K152745ReNew Sterilization Trays (Catalog #3708 and #3709)Microline Surgical, Inc.20160—
+1K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC201530—
+1K141616Sterilization CassetteOticon Medical AB20142—
+1K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc.201330—
+1K130532Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H20136—
+1K121280Myosure Intrument TrayHologic, Inc.20131—
+1K120947THS Instrument TrayHologic, Inc.201230—
+1K110500Stat-Mat MinorMacpherson Medical, Inc.20110—
+1K071783Versapod (TM) Instrument TraysContainmed, Inc.20083—
+1K073551Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div.200813—
+1K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc.20087—
+1K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc.200446—
+1K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH200458—
+1K032119Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc.200318—
+1K030684Scope Guard Protective Sheath, Model Tel-SHAcmi Corporation20030—
+1K023658Sterilization Cases and TraysCarr Metal Products, Inc.200343—
+2K231291Perforated BasketsRichard Wolf Medical Instruments Corporation20240—
+2K210923Southern Implants Instrument TraysSouthern Implants (Pty), Ltd.20220—
+2K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC202031
+2K191566Avinent Surgical TrayAvinent Implant System S.L.U.20202—
+2K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc.20196—
+2K182052Omni Instrument TrayHologic, Inc.20190—
+2K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+2K173642Klockner Surgical BoxSoadco, S.L.20181—
+2K171692Instrument basket, for EndoEYEOlympus Winter & Ibe GmbH20181—
+2K170226iTotal Family Reusable Instrument TrayConformis, Inc.20170—
+2K160730Instrument kitsAnthogyr201720—
+2K161347Signia sterilization trayCovidien20165—
+2K151594Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated20161—
+2K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+2K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization…Paragon Medical, Inc.20151—
+2K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT20131—
+2K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH20120—
+2K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc.20110—
+2K102122Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc.20101—
+2K092551Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div.20100—
+2K100887Versitomic Acl Flexible Reamer System Sterilization TrayTag Medical Products20100—
+2K093800Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC20100—
+2K092414Conmed Detachatip Instrument Tray, 33CM and 43CMConmed Corporation20101—
+2K091806Pogo Screw Instrumentation TrayFxdevices20100—
+2K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc.20095—
+2K091627Smith & Nephew Instrument TraysSmith & Nephew, Inc.20094—
+2K090562Smith & Nephew Instrument TraysSmith & Nephew, Inc.200912—
+2K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc.20084—
+2K070769VHP 136 TraySTERIS Corporation200710—
+2K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec200642—
+2K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation20050Class I
+3K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+3K243128Klockner KitsSoadco, S.L.20240—
+3K230680Anthogyr Surgical CassettesAnthogyr20230—
+3K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+3K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+3K203177Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc.20220—
+3K212068Biotech Dental KitsBiotech Dental, Sas20210—
+3K203492Instrument tray, for semi-rigid ureteroscopeOlympus Winter & Ibe GmbH20210—
+3K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+3K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesAvinent Implant System S.L.U.20210—
+3K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC20212—
+3K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc.20201—
+3K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc.20205—
+3K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+3K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+3K190667Sonopet iQ Sterilization TrayParagon Medical20190—
+3K183199TRIO HandpieceOmniguide, Inc.20190—
+3K180915Sonicision Reusable Sterilization TrayCovidien20181—
+3K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201818—
+3K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+3K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated20170—
+3K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+3K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+3K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation20147—
+3K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation20140—
+3K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H20131—
+3K121904Gynecology Sterilization TraySmith & Nephew Inc., Endoscopy Division20130—
+3K123175Detachatip Iii Plus Instrument Tray Model 3-4343Conmed Corporation20130—
+3K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc.20120—
+3K102544Smith & Nephew Hip Arthroscopy Repair Instrument TraySmith & Nephew Inc., Endoscopy Div.201101
+3K102103Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC20104—
+4K253988LiteSet TraysNobel Biocare AB20260—
+4K251756Sterilization TraysParagon Implant Mfg., LLC20250—
+4K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+4K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC20250—
+4K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—
+4K203468TCAT TKA Instrument TrayTHINK Surgical, Inc.20210—
+4K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc.20210—
+4K201878ST-Z5Z-Systems AG20212—
+4K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC20203—
+4K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+4K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+4K190665Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201913—
+4K181075PureSet TrayNobel Biocare AB20185—
+4K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+4K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+4K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—