510(k) Report

Devices descending from K962545

179 later devices reach Dental, Medical Instrument Cases & Cassette through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022978Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc.200325—
+1K980065C/T Med-Systems Cassette SystemC/T Med System, Ltd.1998152—
+2K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray…Case Medical, Inc.20184—
+2K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)Microline Surgical, Inc.20160—
+2K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC201530—
+2K072563Miltex Rigid Container SystemsMiltex, Inc.20087—
+2K052567One Tray Sealed Sterilization ContainerSterile Containment Technology, LLC200601
+2K053389Aesculap Sterilcontainer SystemAesculap, Inc.200612—
+2K023658Sterilization Cases and TraysCarr Metal Products, Inc.200343—
+2K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc.2002149—
+2K990761Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd.1999150—
+3K242023Microdent Sterilization CassetteImplant Microdent System S.L.U.20250—
+3K212711SteriTite Container System with MediTray ProductsCase Medical, Inc.20223—
+3K210923Southern Implants Instrument TraysSouthern Implants (Pty), Ltd.20220—
+3K203198KARL STORZ Metal Sterilization TraysKarl Storz Endoscopy America, Inc.202111
+3K203572Karl Storz Radel Sterilization TraysKarl Storz Endoscopy America, Inc.202101
+3K201945KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc.202101
+3K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC202031
+3K191566Avinent Surgical TrayAvinent Implant System S.L.U.20202—
+3K173642Klockner Surgical BoxSoadco, S.L.20181—
+3K160730Instrument kitsAnthogyr201720—
+3K162063Steri-Cassette and Steri-Cage Sterilization Packaging SystemSybron Dental Specialties20170—
+3K152745ReNew Sterilization Trays (Catalog #3708 and #3709)Microline Surgical, Inc.20160—
+3K141616Sterilization CassetteOticon Medical AB20142—
+3K131407Bahadir Sterilization TraysBahadir USA Corp.20141—
+3K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc.201330—
+3K130532Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H20136—
+3K121280Myosure Intrument TrayHologic, Inc.20131—
+3K120947THS Instrument TrayHologic, Inc.201230—
+3K112671Sterilcontainer SystemAesculap, Ltd.20127—
+3K110500Stat-Mat MinorMacpherson Medical, Inc.20110—
+3K102146Bahadir Sterilization TraysBahadir USA Corp.201031
+3K092437Codman Sterilization ContainersCodman & Shurtleff, Inc.20102—
+3K071783Versapod (TM) Instrument TraysContainmed, Inc.20083—
+3K073551Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div.200813—
+3K073168Aesculap Primeline Container LTD.Aesculap, Inc.20089—
+3K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc.20087—
+3K062510Aesculap Sterilcontainer SystemAesculap20060—
+3K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec200642—
+3K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc.200446—
+3K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH200458—
+3K032119Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc.200318—
+3K030684Scope Guard Protective Sheath, Model Tel-SHAcmi Corporation20030—
+4K243128Klockner KitsSoadco, S.L.20240—
+4K240898SteriTite rigid reusable sterilization container with MediTray ProductsCase Medical20241—
+4K231291Perforated BasketsRichard Wolf Medical Instruments Corporation20240—
+4K233578Bahadir Sterilization ContainersBahadir USA, LLC20240—
+4K230680Anthogyr Surgical CassettesAnthogyr20230—
+4K221492SteriTite Container System with MediTray PartsCase Medical, Inc.20220—
+4K212068Biotech Dental KitsBiotech Dental, Sas20210—
+4K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesAvinent Implant System S.L.U.20210—
+4K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC20212—
+4K192056JJ Series Container SystemAesculap, Inc.20205—
+4K193582SterilContainer S2 SystemAesculap, Inc.20200—
+4K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc.20196—
+4K182052Omni Instrument TrayHologic, Inc.20190—
+4K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+4K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201818—
+4K171692Instrument basket, for EndoEYEOlympus Winter & Ibe GmbH20181—
+4K172850SterilContainer with PrimeLine Pro LidAesculap, Inc.20170—
+4K170226iTotal Family Reusable Instrument TrayConformis, Inc.20170—
+4K161347Signia sterilization trayCovidien20165—
+4K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.20160—
+4K151594Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated20161—
+4K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+4K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization…Paragon Medical, Inc.20151—
+4K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT20131—
+4K112090Bahadir Sterilization TraysBahadir USA Corp.201221
+4K120117Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc.201211
+4K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH20120—
+4K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc.20110—
+4K102122Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc.20101—
+4K092551Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div.20100—
+4K100887Versitomic Acl Flexible Reamer System Sterilization TrayTag Medical Products20100—
+4K093800Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC20100—
+4K092414Conmed Detachatip Instrument Tray, 33CM and 43CMConmed Corporation20101—
+4K091806Pogo Screw Instrumentation TrayFxdevices20100—
+4K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc.20095—
+4K091627Smith & Nephew Instrument TraysSmith & Nephew, Inc.20094—
+4K090562Smith & Nephew Instrument TraysSmith & Nephew, Inc.200912—
+4K081939Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc.20084—
+4K070769VHP 136 TraySTERIS Corporation200710—
+4K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation20050Class I
+5K253988LiteSet TraysNobel Biocare AB20260—
+5K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.20260—
+5K251756Sterilization TraysParagon Implant Mfg., LLC20250—
+5K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+5K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+5K214041Aesculap AICON ContainerAesculap, Inc.20224—
+5K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+5K203177Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc.20220—
+5K203492Instrument tray, for semi-rigid ureteroscopeOlympus Winter & Ibe GmbH20210—
+5K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+5K201878ST-Z5Z-Systems AG20212—
+5K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc.20201—
+5K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc.20205—
+5K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+5K190665Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+5K190667Sonopet iQ Sterilization TrayParagon Medical20190—