510(k) Report

Devices descending from K040223

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc.201330—
+1K121280Myosure Intrument TrayHologic, Inc.20131—
+1K120947THS Instrument TrayHologic, Inc.201230—
+1K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc.20110—
+1K091806Pogo Screw Instrumentation TrayFxdevices20100—
+1K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc.20095—
+1K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc.20084—
+2K183199TRIO HandpieceOmniguide, Inc.20190—
+2K182052Omni Instrument TrayHologic, Inc.20190—
+2K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+2K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+2K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT20131—
+2K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc.20120—
+2K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH20120—
+3K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+3K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+3K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+3K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+3K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+3K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation20140—
+4K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+4K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+4K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+4K181075PureSet TrayNobel Biocare AB20185—
+4K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+4K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+5K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+5K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+5K212281Surgical TraysDentsply Sirona, Inc.20225—
+5K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+5K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+5K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+5K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+5K191522Straumann Modular CassetteInstitut Straumann AG20192—
+5K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+5K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+5K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+6K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+6K231144WashtraysDentsply Sirona20240—
+6K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+6K223672Instrument Case P1340904Cochlear20231—
+6K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+6K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+7K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+7K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+7K231604Instrument CaseCochlear Americas20230—