510(k) Report

Devices descending from K013003

83 later devices reach Aptimax Instrument Tray, Instrument Mat and Instrument Holder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…Advanced Sterilization Products20242—
+1K103226Sterilization MatsSTERIS Corporation20118—
+1K103213Finess Endoscope Sterilization TrayEntellus Medical, Inc.201122—
+1K070769VHP 136 TraySTERIS Corporation200710—
+1K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc.200446—
+2K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.20251—
+2K133942Endoscope Sterilization TrayIntuitive Surgical201419—
+2K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation20147—
+2K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc.201330—
+2K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H20131—
+2K121280Myosure Intrument TrayHologic, Inc.20131—
+2K120947THS Instrument TrayHologic, Inc.201230—
+2K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc.20110—
+2K091806Pogo Screw Instrumentation TrayFxdevices20100—
+2K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc.20095—
+2K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc.20084—
+3K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.20260—
+3K183199TRIO HandpieceOmniguide, Inc.20190—
+3K182052Omni Instrument TrayHologic, Inc.20190—
+3K160912Sterilization TraySTERIS Corporation20166—
+3K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+3K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments20150—
+3K142937Endoscope Sterilization TrayIntuitive Surgical, Inc.201516—
+3K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+3K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+3K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT20131—
+3K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc.20120—
+3K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH20120—
+4K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+4K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+4K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+4K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+4K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+4K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+4K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+4K151450Endoscope Sterilization TrayIntuitive Surgical, Inc.201615—
+4K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation20140—
+5K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+5K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+5K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+5K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+5K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+5K181075PureSet TrayNobel Biocare AB20185—
+5K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+5K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+5K170640Endoscope Sterilization TrayIntuitive Surgical, Inc.201714—
+6K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+6K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+6K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+6K212281Surgical TraysDentsply Sirona, Inc.20225—
+6K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+6K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+6K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+6K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+6K191522Straumann Modular CassetteInstitut Straumann AG20192—
+6K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+6K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+6K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+6K180964Endoscope Sterilization TrayIntuitive Surgical, Inc.201813—
+7K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+7K231144WashtraysDentsply Sirona20240—
+7K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+7K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+7K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—
+7K223672Instrument Case P1340904Cochlear20231—
+7K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+7K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+7K183139Endoscope Sterilization TrayIntuitive Surgical, Inc.2019121
+8K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+8K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+8K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+8K231604Instrument CaseCochlear Americas20230—
+9K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+9K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+9K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+9K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+9K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+9K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+9K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+10K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+10K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+10K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+10K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—