510(k) Report

Devices descending from K033222

58 later devices reach Olympus Sterilization Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171692Instrument basket, for EndoEYEOlympus Winter & Ibe GmbH20181—
+1K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+1K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT20131—
+1K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH20120—
+1K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc.20095—
+1K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc.20087—
+1K070769VHP 136 TraySTERIS Corporation200710—
+1K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation20050Class I
+2K203492Instrument tray, for semi-rigid ureteroscopeOlympus Winter & Ibe GmbH20210—
+2K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+2K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+2K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc.20196—
+2K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+2K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+2K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation20147—
+2K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation20140—
+2K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H20131—
+2K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc.20120—
+2K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc.20110—
+3K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+3K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+3K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc.20205—
+3K181075PureSet TrayNobel Biocare AB20185—
+3K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+3K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+3K160912Sterilization TraySTERIS Corporation20166—
+3K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments20150—
+4K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+4K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+4K212281Surgical TraysDentsply Sirona, Inc.20225—
+4K203468TCAT TKA Instrument TrayTHINK Surgical, Inc.20210—
+4K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+4K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+4K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+4K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+4K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC20203—
+4K191522Straumann Modular CassetteInstitut Straumann AG20192—
+4K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+4K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+4K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+4K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+5K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+5K241927Synthes Graphic Case & Tray SystemSynthes GmbH20251—
+5K241050CrossRoads Modular Tray SystemCrossroads Extremity Systems20240—
+5K231144WashtraysDentsply Sirona20240—
+5K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+5K223672Instrument Case P1340904Cochlear20231—
+5K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+5K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+5K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+5K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+6K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+6K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.20260—
+6K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+6K231604Instrument CaseCochlear Americas20230—
+6K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+7K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+7K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—