Product Code: KCT
FDA class 2
21 CFR 880.6850
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
General Hospital
Sterilization wrap containers, trays, cassettes, and related accessories are devices used to package, protect, and maintain the sterility of surgical instruments and other reusable medical devices during sterilization processes and subsequent storage until point of use. They are classified as FDA Class 2 devices, indicating moderate risk, and require 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KCT is regulated under 21 CFR 880.6850 in the General Hospital medical specialty. This device is eligible for third-party review under FDA's accredited persons program.
510(k)s
271
FEI Numbers
265
Registration Numbers
265
Unique Applicants
174
Years Active
49
Basic Information
- Product Code
- KCT
- Device Class
- FDA class 2
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 271 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243589 | PAL Sterilization Case | Jun 20, 2025 | Substantially Equivalent | MicroAire Surgical Instruments, LLC |
| K242762 | Aesculap Aicon® Series Container System | May 13, 2025 | Substantially Equivalent | Aesculap Inc. |
| K250029 | ONE TRAY® Sealed Sterilization Container System | May 01, 2025 | Substantially Equivalent | Innovative Sterilization Technologies |
| K241927 | Synthes Graphic Case & Tray System | Mar 28, 2025 | Substantially Equivalent | Synthes GmbH |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Mar 21, 2025 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K242023 | Microdent Sterilization Cassette | Feb 19, 2025 | Substantially Equivalent | Implant Microdent System S.L.U. |
| K243317 | NUVENTUS NV.C Surgical Cassette and Tray | Feb 11, 2025 | Substantially Equivalent | Infinitum Eta Ltd. |
| K242834 | System 9 Sterile Battery Container | Jan 16, 2025 | Substantially Equivalent | Stryker Instruments |
| K243128 | Klockner Kits | Dec 18, 2024 | Substantially Equivalent | Soadco, S.L. |
| K241492 | Guided Surgery Kit Cases | Aug 23, 2024 | Substantially Equivalent | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Jul 31, 2024 | Substantially Equivalent | Case Medical |
| K241050 | CrossRoads Modular Tray System | Jul 16, 2024 | Substantially Equivalent | CrossRoads Extremity Systems |
| K241378 | S.I.N. Instrument Kits | Jul 12, 2024 | Substantially Equivalent | S.I.N. - Sistema de Implante Nacional S.A. |
| K231291 | Perforated Baskets | Jun 03, 2024 | Substantially Equivalent | Richard Wolf Medical Instruments Corporation |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Mar 22, 2024 | Substantially Equivalent | Bahadir USA LLC |
| K231144 | Washtrays | Jan 16, 2024 | Substantially Equivalent | Dentsply Sirona |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Dec 22, 2023 | Substantially Equivalent | Anthogyr |
| K233222 | Aygün Sterilization Container Systems | Dec 12, 2023 | Substantially Equivalent | Aygun Surgical Instruments Co., Inc. |
| K231604 | Instrument Case | Aug 24, 2023 | Substantially Equivalent | Cochlear Americas |
| K231501 | PRO-LITE Sterilization Tray | Aug 07, 2023 | Substantially Equivalent | STERIS Corporation |
| K230680 | Anthogyr Surgical Cassettes | Jul 11, 2023 | Substantially Equivalent | Anthogyr |
| K230804 | Complement Kit Cases | Jul 07, 2023 | Substantially Equivalent | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K231219 | NobelZygoma PureSet Tray | Jun 27, 2023 | Substantially Equivalent | Nobel Biocare Services AG |
| K222640 | Sweden & Martina Surgical Trays | May 26, 2023 | Substantially Equivalent | Sweden & Martina S.p.A. |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Apr 20, 2023 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K223672 | Instrument Case P1340904 | Mar 21, 2023 | Substantially Equivalent | Cochlear |
| K214041 | Aesculap AICON Container | Dec 30, 2022 | Substantially Equivalent | Aesculap Inc. |
| K222514 | S.I.N. Instrument Kits | Oct 27, 2022 | Substantially Equivalent | S.I.N. Sistema de Implante Nacional S.A. |
| K221492 | SteriTite Container System with MediTray Parts | Oct 07, 2022 | Substantially Equivalent | Case Medical, Inc. |
| K222005 | S.I.N. Instrument Kits | Sep 29, 2022 | Substantially Equivalent | S.I.N. - Sistema De Implante Nacional S.A. |
| K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Sep 28, 2022 | Substantially Equivalent | SteriCUBE, LLC |
| K220791 | Surgical and Prosthetic Trays | May 03, 2022 | Substantially Equivalent | Dentsply Sirona |
| K212711 | SteriTite Container System with MediTray Products | Apr 29, 2022 | Substantially Equivalent | Case Medical, Inc. |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | Apr 13, 2022 | Substantially Equivalent | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K212281 | Surgical Trays | Mar 04, 2022 | Substantially Equivalent | Dentsply Sirona Inc. |
| K210923 | Southern Implants Instrument Trays | Mar 02, 2022 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K203177 | Sterisystem Dry-Base Instrument Tray | Jan 02, 2022 | Substantially Equivalent | O&M Halyard, Inc |
| K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | Dec 28, 2021 | Substantially Equivalent | K1 Medical LLC |
| K203468 | TCAT TKA Instrument Tray | Dec 20, 2021 | Substantially Equivalent | THINK Surgical, Inc. |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | Dec 18, 2021 | Substantially Equivalent | Nobel Biocare Services AG |
| K210836 | InstruSafe Instrument Protection System | Nov 30, 2021 | Substantially Equivalent | Summitt Medical LLC |
| K212068 | Biotech Dental Kits | Nov 08, 2021 | Substantially Equivalent | Biotech Dental, SAS |
| K212404 | S.I.N. Instrument Kits | Nov 03, 2021 | Substantially Equivalent | S.I.N. - Sistema de Implante Nacional S.A. |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | Oct 22, 2021 | Substantially Equivalent | NeoTract, Inc. |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Sep 15, 2021 | Substantially Equivalent | Olympus Winter & Ibe GmbH |
| K203753 | Straumann Surgical Cassettes | Jul 29, 2021 | Substantially Equivalent | Straumann USA, LLC |
| K203198 | KARL STORZ Metal Sterilization Trays | Jul 06, 2021 | Substantially Equivalent | Karl Storz Endoscopy America Inc |
| K211007 | EZ-TRAXTM Persona Knee Containment Device | Jul 01, 2021 | Substantially Equivalent | K1 Medical LLC |
| K203572 | Karl Storz Radel Sterilization Trays | May 07, 2021 | Substantially Equivalent | Karl Storz Endoscopy America Inc |
| K201878 | ST-Z5 | Mar 25, 2021 | Substantially Equivalent | Z-Systems AG |
| K203618 | Neodent EasyGuide Kit Cases | Mar 09, 2021 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K201533 | Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes | Mar 01, 2021 | Substantially Equivalent | AVINENT Implant System S.L.U. |
| K201945 | KARL STORZ UDEL Sterilization Trays | Feb 25, 2021 | Substantially Equivalent | Karl Storz EndoscopyAmerica Inc |
| K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit | Feb 18, 2021 | Substantially Equivalent | BEGO Implant Systems GmbH & Co. KG |
| K202524 | Standard Sterilizable Tray | Jan 28, 2021 | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC |
| K202268 | CrossRoads Tray System | Dec 30, 2020 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | Dec 02, 2020 | Substantially Equivalent | K1 Medical LLC |
| K202515 | NUVO Implant System NUVO Instrument Kit Cases | Nov 24, 2020 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Nov 04, 2020 | Substantially Equivalent | Sweden & Martina S.p.A. |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Oct 29, 2020 | Substantially Equivalent | OsteoMed LLC |
| K201688 | S.I.N. Instrument Kits | Oct 21, 2020 | Substantially Equivalent | S.I.N. - Sistema de Implante Nacional S.A. |
| K200858 | Mini Sterilizable Tray | Aug 06, 2020 | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC |
| K193066 | Steripack cases and Tray Systems | Aug 06, 2020 | Substantially Equivalent | Avalign Technologies, Inc. |
| K193603 | Benesta Medical Sterilization Tray | Jul 20, 2020 | Substantially Equivalent | Caldera Medical, Inc |
| K192781 | UroLift System Procedure Kit Sterilization Tray | Apr 14, 2020 | Substantially Equivalent | NeoTract, Inc. |
| K200632 | TCAT TKA Instrument Tray Set | Apr 08, 2020 | Substantially Equivalent | THINK Surgical, Inc. |
| K192056 | JJ Series Container System | Mar 27, 2020 | Substantially Equivalent | Aesculap, Inc. |
| K193582 | SterilContainer S2 System | Mar 17, 2020 | Substantially Equivalent | Aesculap, Inc. |
| K191566 | Avinent Surgical Tray | Mar 06, 2020 | Substantially Equivalent | AVINENT Implant System, S.L.U. |
| K192487 | EZ-TRAX Containment Device | Dec 23, 2019 | Substantially Equivalent | K1 Medical LLC |
| K190665 | Neodent Instrument Kit Cases | Dec 23, 2019 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K192670 | Neodent Instrument Kit Cases | Dec 18, 2019 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K191522 | Straumann Modular Cassette | Dec 03, 2019 | Substantially Equivalent | Institut Straumann AG |
| K181845 | Pivot System Sterilization case | Nov 25, 2019 | Substantially Equivalent | RP Medical, Inc. |
| K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Nov 05, 2019 | Substantially Equivalent | PMBS, LLC |
| K190840 | Medtronic Transportation / Sterilization Cassettes | Oct 15, 2019 | Substantially Equivalent | Medtronic Sofamor Danek USA, INC. |
| K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | Aug 29, 2019 | Substantially Equivalent | Nobel Biocare AB |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Jul 05, 2019 | Substantially Equivalent | Aesculap, Inc. |
| K190667 | Sonopet iQ Sterilization Tray | Jun 13, 2019 | Substantially Equivalent | Paragon Medical |
| K181933 | DePuy Synthes Sterilization Container System | May 09, 2019 | Substantially Equivalent | Synthes (USA) Products LLC / DePuy Orthopaedics Inc. |
| K183701 | Stryker ChestShield Sterilization Tray System | May 07, 2019 | Substantially Equivalent | Paragon Medical |
| K182865 | Neodent Instruments Kits | May 07, 2019 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K180127 | TCAT (R) THA Instrument Tray Set | Mar 15, 2019 | Substantially Equivalent | THINK Surgical Inc. |
| K183402 | PRO-LITE Sterilization Tray | Mar 01, 2019 | Substantially Equivalent | STERIS Corporation |
| K182052 | Omni Instrument Tray | Feb 26, 2019 | Substantially Equivalent | Hologic, Inc |
| K183139 | Endoscope Sterilization Tray | Feb 01, 2019 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K183301 | PRO-LITE Sterilization Tray | Jan 03, 2019 | Substantially Equivalent | STERIS Corporation |
| K182032 | SterilContainer S System | Dec 21, 2018 | Substantially Equivalent | Aesculap, Inc. |
| K180528 | InstruSafe(R) Sterilization Container | Nov 16, 2018 | Substantially Equivalent | Summit Medical Inc. |
| K173642 | KLOCKNER SURGICAL BOX | Oct 02, 2018 | Substantially Equivalent | Soadco, S.L. |
| K180964 | Endoscope Sterilization Tray | Sep 28, 2018 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K181075 | PureSet Tray | Sep 27, 2018 | Substantially Equivalent | Nobel Biocare AB |
| K180915 | Sonicision Reusable Sterilization Tray | Jul 17, 2018 | Substantially Equivalent | Covidien |
| K180791 | Straumann BLX Surgical Cassette | Jun 21, 2018 | Substantially Equivalent | Institut Straumann AG |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | Jun 13, 2018 | Substantially Equivalent | Case Medical, Inc |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | May 10, 2018 | Substantially Equivalent | OsteoMed LLC |
| K173615 | Stryker Universal Select Sterilization Tray System | Apr 18, 2018 | Substantially Equivalent | Paragon Medical |
| K171713 | Neodent Instrument Kits | Apr 05, 2018 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K171692 | Instrument basket, for EndoEYE | Apr 02, 2018 | Substantially Equivalent | Olympus Winter & Ibe GmbH |
| K172755 | PRO-LITE Sterilization Trays | Feb 09, 2018 | Substantially Equivalent | Steris Corporation |
| K171520 | SteriZign Signatur Device Protection System | Feb 07, 2018 | Substantially Equivalent | SteriZign Precision Technologies, LLC |
| K163600 | Kit Boxes and Kit Plates | Jan 22, 2018 | Substantially Equivalent | Nobel Biocare AB |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | Nov 24, 2017 | Substantially Equivalent | SciCan Ltd. |
| K172850 | SterilContainer with PrimeLine Pro Lid | Nov 17, 2017 | Substantially Equivalent | Aesculap, Inc. |
| K170226 | iTotal Family Reusable Instrument Tray | Oct 25, 2017 | Substantially Equivalent | CONFORMIS, INC |
| K170640 | Endoscope Sterilization Tray | Sep 17, 2017 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K170939 | Supplemental Instrument Trays | Aug 08, 2017 | Substantially Equivalent | NuVasive Specialized Orthopedics, Incorporated |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | Jul 31, 2017 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K162815 | SterilContainer S System | Jul 13, 2017 | Substantially Equivalent | AESCULAP, INC |
| K160730 | Instrument kits | Apr 27, 2017 | Substantially Equivalent | ANTHOGYR |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Apr 21, 2017 | Substantially Equivalent | Sybron Dental Specialties |
| K163279 | Medtronic Transportation/Sterilization Cassettes | Feb 23, 2017 | Substantially Equivalent | Medtronic Sofamor Danek, USA, Inc. |
| K160574 | K3PRO SURGICAL TRAY | Dec 20, 2016 | Substantially Equivalent | ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
| K162600 | Jewel Precision Reusable Rigid Sterilization Container System | Dec 09, 2016 | Substantially Equivalent | JEWEL PRECISION SHEET METAL & MACHINE, INC. |
| K160912 | Sterilization Tray | Oct 07, 2016 | Substantially Equivalent | STERIS CORPORATION |
| K161347 | Signia sterilization tray | Sep 07, 2016 | Substantially Equivalent | COVIDIEN |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | May 12, 2016 | Substantially Equivalent | MICROLINE SURGICAL, INC. |
| K152111 | Symmetry Surgical Quad-Lock Container System | Apr 14, 2016 | Substantially Equivalent | SYMMETRY SURGICAL INC. |
| K152969 | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY | Mar 31, 2016 | Substantially Equivalent | CONMED CORPORATION |
| K153554 | Genesis Low Temperature Reusable Rigid Container System | Mar 21, 2016 | Substantially Equivalent | CareFusion 2200 Inc |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | Feb 08, 2016 | Substantially Equivalent | MICROLINE SURGICAL, INC. |
| K151594 | Ellipse Supplemental Instrument Trays | Jan 25, 2016 | Substantially Equivalent | Ellipse Technologies, Incorporated |
| K152241 | Medtronic Transportation/Sterilization Cassettes | Jan 20, 2016 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K151450 | Endoscope Sterilization Tray | Jan 12, 2016 | Substantially Equivalent | INTUITIVE SURGICAL, INC. |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray | Dec 28, 2015 | Substantially Equivalent | PARAGON MEDICAL, INC. |
| K141854 | INSTRUMENT CASSETTE (EFCCL1-F) | Oct 29, 2015 | Substantially Equivalent | OSUNG MND CO., LTD |
| K152014 | MTS300 Multiple Tray Sterilization System | Oct 20, 2015 | Substantially Equivalent | PMBS, LLC |
| K151347 | MIS Spine Frame Instrument Case | Oct 16, 2015 | Substantially Equivalent | THOMPSON SURGICAL INSTRUMENTS |
| K151242 | SterilContainer S | Oct 09, 2015 | Substantially Equivalent | Aesculap, Inc. |
| K143579 | NuVasive Sterilization Trays | Aug 28, 2015 | Substantially Equivalent | NuVasive, Incorporated |
| K151166 | Instru-Safe Instrument Protection System | Aug 18, 2015 | Substantially Equivalent | Summit Medical Inc. |
| K143729 | SterilContainer S | Aug 18, 2015 | Substantially Equivalent | AESCULAP, INC. |
| K142970 | SterilContainer S System | Jul 08, 2015 | Substantially Equivalent | AESCULAP, INC. |
| K150540 | Instru-Safe Instrument Protection System | Jun 22, 2015 | Substantially Equivalent | SUMMIT MEDICAL, INC. |
| K142768 | Instru-Safe Instrument Protection System | May 29, 2015 | Substantially Equivalent | SUMMIT MEDICAL, INC. |
| K142519 | InterActive Complete Surgical Tray | Apr 15, 2015 | Substantially Equivalent | Implant Direct Sybron Manufacturing , LLC |
| K142937 | Endoscope Sterilization Tray | Feb 24, 2015 | Substantially Equivalent | INTUITIVE SURGICAL, INC. |
| K142109 | STERILUCENT STERILIZATION CONTAINER SYSTEM | Jan 20, 2015 | Substantially Equivalent | STERILUCENT, INC |
| K142529 | Genesis Reusable Rigid Container System | Jan 08, 2015 | Substantially Equivalent | CareFusion 2200 Inc |
| K142630 | Instru-Safe Instrument Protection System | Dec 23, 2014 | Substantially Equivalent | Summit Medical Inc. |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Dec 15, 2014 | Substantially Equivalent | SUMMIT MEDICAL, INC. |
| K141616 | STERILIZATION CASSETTE | Sep 23, 2014 | Substantially Equivalent | OTICON MEDICAL AB |
| K140850 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | Aug 27, 2014 | Substantially Equivalent | CAREFUSION 2200, INC. |
| K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM | Aug 14, 2014 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K131407 | BAHADIR STERILIZATION TRAYS | Aug 12, 2014 | Substantially Equivalent | BAHADIR USA CORP. |
| K133942 | ENDOSCOPE STERILIZATION TRAY | Aug 01, 2014 | Substantially Equivalent | INTUITIVE SURGICAL |
| K140494 | V-PRO STERILIZATION TRAY/ STERILIZATION MAT | Jul 25, 2014 | Substantially Equivalent | STERIS Corporation |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Jun 27, 2014 | Substantially Equivalent | SUMMIT MEDICAL, INC. |
| K133116 | VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC | Mar 28, 2014 | Substantially Equivalent | CONMED CORPORATION |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Mar 13, 2014 | Substantially Equivalent | SUMMIT MEDICAL, INC. |
| K131455 | RESTORE MODULAR STERILIZATION TRAY SYSTEM | Aug 30, 2013 | Substantially Equivalent | RESTORE MEDICAL SOLUTIONS, INC. |
| K131170 | SONICISION STERILIZATION TRAY | Aug 28, 2013 | Substantially Equivalent | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
| K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | Jul 05, 2013 | Substantially Equivalent | ERMIS MEDIZINTECHNIK |
| K130532 | IDRIVE ULTRA STERILIZATION TRAY | May 30, 2013 | Substantially Equivalent | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
| K121904 | GYNECOLOGY STERILIZATION TRAY | Mar 11, 2013 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K123175 | DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 | Feb 21, 2013 | Substantially Equivalent | CONMED CORPORATION |
| K121280 | MYOSURE INTRUMENT TRAY | Feb 08, 2013 | Substantially Equivalent | HOLOGIC, INC. |
| K122818 | OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE | Jan 04, 2013 | Substantially Equivalent | OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT |
| K120947 | THS INSTRUMENT TRAY | Oct 17, 2012 | Substantially Equivalent | HOLOGIC, INC. |
| K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | Oct 15, 2012 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K110898 | S.C.O.R.E.S. UNIT | Jul 26, 2012 | Substantially Equivalent | AMMED SURGICAL EQUIPMENT, LLC |
| K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY | Jul 10, 2012 | Substantially Equivalent | GYRUS ACMI, INC. |
| K112090 | BAHADIR STERILIZATION TRAYS | Jun 07, 2012 | Substantially Equivalent | BAHADIR USA CORP. |
| K112671 | STERILCONTAINER SYSTEM | May 04, 2012 | Substantially Equivalent | AESCULAP, LTD. |
| K112535 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | Apr 27, 2012 | Substantially Equivalent | CAREFUSION 2200, INC. |
| K112536 | SONICISION STERILIZATION TRAY | Apr 19, 2012 | Substantially Equivalent | COVIDIEN |
| K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM | Apr 16, 2012 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K110748 | OLYMPUS INSTRUMENT TRAY | Feb 15, 2012 | Substantially Equivalent | OLYMPUS WINTER & IBE GMBH |
| K110682 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | Jul 01, 2011 | Substantially Equivalent | CASE MEDICAL, INC. |
| K110500 | STAT-MAT MINOR | Jun 23, 2011 | Substantially Equivalent | MACPHERSON MEDICAL, INC. |
| K102970 | GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT | May 20, 2011 | Substantially Equivalent | GYRUS ACMI, INC. |
| K103226 | STERILIZATION MATS | Feb 18, 2011 | Substantially Equivalent | STERIS Corporation |
| K103213 | FINESS ENDOSCOPE STERILIZATION TRAY | Feb 02, 2011 | Substantially Equivalent | Entellus Medical, Inc. |
| K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY | Jan 05, 2011 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K102103 | SKELETAL DYNAMICS STERILIZATION TRAYS | Dec 07, 2010 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K102122 | SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 | Nov 22, 2010 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K092745 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU | Nov 19, 2010 | Substantially Equivalent | STERIS Corporation |
| K102146 | BAHADIR STERILIZATION TRAYS | Nov 18, 2010 | Substantially Equivalent | BAHADIR USA CORP. |
| K092551 | SMITH & NEPHEW INSTRUMENT TRAYS | Sep 14, 2010 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K100887 | VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY | Aug 09, 2010 | Substantially Equivalent | T.A.G. MEDICAL PRODUCTS |
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | Aug 02, 2010 | Substantially Equivalent | MILTEX, INC. |
| K093800 | ROBINSON MEDSURG QUICKSCREW RACK | Jun 16, 2010 | Substantially Equivalent | ROBINSON MEDSURG LLC |
| K091720 | SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM | Apr 09, 2010 | Substantially Equivalent | SKLAR CORP. |
| K092437 | CODMAN STERILIZATION CONTAINERS | Mar 25, 2010 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K092414 | CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM | Mar 10, 2010 | Substantially Equivalent | CONMED CORPORATION |
| K091806 | POGO SCREW INSTRUMENTATION TRAY | Feb 22, 2010 | Substantially Equivalent | FXDEVICES |
| K092682 | GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS | Dec 11, 2009 | Substantially Equivalent | GYRUS ACMI, INC. |
| K090818 | KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS | Aug 18, 2009 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K091627 | SMITH & NEPHEW INSTRUMENT TRAYS | Jul 02, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K090560 | CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS | Jun 29, 2009 | Substantially Equivalent | CONMED LINVATEC |
| K090371 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM | May 01, 2009 | Substantially Equivalent | STERIS Corporation |
| K090562 | SMITH & NEPHEW INSTRUMENT TRAYS | Mar 18, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K071783 | VERSAPOD (TM) INSTRUMENT TRAYS | Sep 09, 2008 | Substantially Equivalent | CONTAINMED, INC. |
| K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | Sep 05, 2008 | Substantially Equivalent | CONMED LINVATEC |
| K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | May 21, 2008 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K073168 | AESCULAP PRIMELINE CONTAINER LTD. | Apr 28, 2008 | Substantially Equivalent | AESCULAP, INC. |
| K072211 | INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS | Feb 28, 2008 | Substantially Equivalent | INTUITIVE SURGICAL, INC. |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | Feb 12, 2008 | Substantially Equivalent | MILTEX, INC. |
| K070765 | VIS-U-ALL II SELF SEAL POUCH | Oct 12, 2007 | Substantially Equivalent | STERIS Corporation |
| K070769 | VHP 136 TRAY | Oct 05, 2007 | Substantially Equivalent | STERIS Corporation |
| K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | Jul 17, 2007 | Substantially Equivalent | A.R. MEDICOM, INC. |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | Dec 12, 2006 | Substantially Equivalent | MILTEX, INC. |
| K052567 | ONE TRAY SEALED STERILIZATION CONTAINER | Mar 13, 2006 | Substantially Equivalent | STERILE CONTAINMENT TECHNOLOGY, LLC. |
| K051242 | WINNER SELF SEAL STERILIZATION POUCH | Dec 13, 2005 | Substantially Equivalent | WINNER MEDICAL (USA), INC. |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Sep 01, 2005 | Substantially Equivalent | MICROMEDICS, INC. |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | Jul 25, 2005 | Substantially Equivalent | MILTEX, INC. |
| K040223 | POLYVAC INSTRUMENT DELIVERY SYSTEM | Oct 22, 2004 | Substantially Equivalent | SYMMETRY MEDICAL USA INC. |
| K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE | Sep 30, 2004 | Substantially Equivalent | BARD PERIPHERAL VASCULAR, INC. |
| K033222 | OLYMPUS STERILIZATION TRAYS | Aug 02, 2004 | Substantially Equivalent | OLYMPUS WINTER & IBE GMBH |
| K032445 | THE ULTRA SYSTEM | Mar 29, 2004 | Substantially Equivalent | PROMEDICA, INC. |
| K032813 | THE ULTRA SYSTEM SP | Feb 13, 2004 | Substantially Equivalent | PROMEDICA, INC. |
| K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | Oct 29, 2003 | Substantially Equivalent | PARAGON MEDICAL, INC. |
| K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | Aug 02, 2002 | Substantially Equivalent | SYMMETRY MEDICAL, INC. |
| K993764 | MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH | Dec 16, 1999 | Substantially Equivalent | MEDIPACK MEDICAL PACKAGING MFG. CO. |
| K972719 | CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS | Feb 04, 1999 | Substantially Equivalent | MEDICEL, S.A. DE C.V. |
| K980065 | C/T MED-SYSTEMS CASSETTE SYSTEM | May 11, 1998 | Substantially Equivalent | C/T MED SYSTEM, LTD. |
| K973827 | KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION | Feb 11, 1998 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K973981 | SAFEPASS STERILIZATION POUCH | Jan 29, 1998 | Substantially Equivalent | ADROIT MEDICAL SYSTEMS, INC. |
| K973440 | REXAM FRACTURE RESISTANT POUCH | Oct 20, 1997 | Substantially Equivalent | REXAM MEDICAL PACKAGING, INC. |
| K960738 | STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) | May 06, 1997 | Substantially Equivalent | ENGINEERED CUSTOM MFG., INC. |
| K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | Mar 07, 1997 | Substantially Equivalent | STERILIZATION CASSETTE SYSTEMS, INC. |
| K962600 | REXAM SELF-SEAL TYVEK POUCH | Aug 09, 1996 | Substantially Equivalent | REXAM MEDICAL PACKAGING, INC. |
| K953068 | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER | Jan 23, 1996 | Substantially Equivalent | OXBORO MEDICAL INTL., INC. |
| K952787 | FOAM INSTRUMENT GUARD | Dec 28, 1995 | Substantially Equivalent | OXBORO MEDICAL INTL., INC. |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | Dec 04, 1995 | Unknown | MILTEX, INC. |
| K954090 | AUTO SUTURE* STERILIZATION TRAY** | Nov 22, 1995 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K953829 | SAFE-T-SEAL | Nov 09, 1995 | Substantially Equivalent | GS MEDICAL PACKAGING, INC. |
| K953749 | MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS | Oct 19, 1995 | Substantially Equivalent | CURWOOD, INC. |
| K953776 | STERIKING STERILIZATION POUCHES & ROLLS | Oct 12, 1995 | Substantially Equivalent | WIHURI OY |
| K951295 | STERRAD STERILIZATION POUCH | May 19, 1995 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K951590 | ASSURE, SELF-SEALING STERILIZATION POUCH | May 17, 1995 | Substantially Equivalent | SULTAN CHEMISTS, INC. |
| K935755 | THE ULTRA | May 05, 1995 | Substantially Equivalent | MEDICAL DEVICE SYSTEMS, INC. |
| K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | Dec 22, 1994 | Substantially Equivalent | CROSS COUNTRY PAPER PRODUCTS CORP. |
| K944864 | PRIMED RIGID CONTAINER SYSTEM | Dec 20, 1994 | Substantially Equivalent | PRIMED, INC. |
| K945055 | HARKEN ASSURE SELF-SEAL STERILIZATION POUCH | Dec 14, 1994 | Substantially Equivalent | HARKEN PRODUCTS, INC. |
| K940807 | SEE-THRU SELF SEALING STERILIZATION POUCH | Nov 18, 1994 | Substantially Equivalent | ASEP-PRO, INC. |
| K932088 | AUTOPAK STERILIZATION POUCH | Nov 17, 1994 | Substantially Equivalent | ONGARD MEDDEVICE PACKAGING, INC. |
| K932086 | AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH | Nov 17, 1994 | Substantially Equivalent | ONGARD MEDDEVICE PACKAGING, INC. |
| K922440 | STERIKING, SEE & PEEL | Sep 26, 1994 | Substantially Equivalent | COX STERILE PRODUCTS, INC. |
| K932056 | DEFEND SELF-SEALING STERILIZATION POUCH | Jul 13, 1994 | Substantially Equivalent | CARL PARKER ASSOCIATES, INC. |
| K933729 | ASSURE SELF SEALING STERILIZATION POUCH | Jun 21, 1994 | Substantially Equivalent | SULTAN CHEMISTS, INC. |
| K934252 | RPPI STERILIZATION BAGS | Jun 17, 1994 | Substantially Equivalent | ROYAL PRECISION PLASTICS, INC. |
| K930072 | STERITUBE | Jun 17, 1994 | Substantially Equivalent | JORDCO, INC. |
| K933560 | BARRIER PLASTIC PACKAGING (MODIFICATION) | Apr 11, 1994 | Substantially Equivalent | MAXXIM MEDICAL |
| K935739 | SHAVE PREP TRAY | Feb 09, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K924118 | PROPAK | Jul 13, 1993 | Substantially Equivalent | DENTAL SERVICES, INC. |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Apr 04, 1990 | Substantially Equivalent | COTTRELL, LTD. |
| K891210 | POCKETED WRAPS #3009 A,B,C | Oct 13, 1989 | Substantially Equivalent | PRO-SAFE PROFESSIONAL LINENS, INC. |
| K891983 | CAM-WRAP(TM) NEW STERILIZATION PROCEDURE | Apr 19, 1989 | Substantially Equivalent | MEDICAL DYNAMICS, INC. |
| K891215 | FAST WRAP #M 101 | Apr 14, 1989 | Substantially Equivalent | PRO-SAFE PROFESSIONAL LINENS, INC. |
| K891214 | DENTAL SURGICAL WRAP #3007 A,B,C | Apr 14, 1989 | Substantially Equivalent | PRO-SAFE PROFESSIONAL LINENS, INC. |
| K891213 | SURGICAL INSTRUMENT POUCH #M102 | Apr 14, 1989 | Substantially Equivalent | PRO-SAFE PROFESSIONAL LINENS, INC. |
| K884041 | MASTER-GUARD | Oct 07, 1988 | Substantially Equivalent | SPARCO, INC. |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Jul 15, 1986 | Substantially Equivalent | KEYMED, INC. |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent | MICROVASIVE |
| K834558 | CK10000 SERIES POUCH & BAGS ETC. | Sep 05, 1984 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K832128 | SELF-SEAL STERILIZATION POUCHES | Aug 08, 1983 | Substantially Equivalent | MEDICAL INDUSTRIES PACKAGING, INC. |
| K831588 | INSTRUMENT GUARD CAPSULE | Jun 15, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K831165 | DUSTCOVERS/STERILITY MAINTENANCE COVERS | May 03, 1983 | Substantially Equivalent | MEDICAL INDUSTRIES PACKAGING, INC. |
| K830961 | EASY BREATHER HEADER BAGS | Apr 12, 1983 | Substantially Equivalent | MEDICAL INDUSTRIES PACKAGING, INC. |
| K821332 | DUSTCOVERS &/OR STERILITY MAINT. COVERS | May 27, 1982 | Substantially Equivalent | MEDICAL INDUSTRIES PACKAGING, INC. |
| K810469 | STERILEDGE SELF SEAL POUCH | Jun 01, 1981 | Substantially Equivalent | BEACON CONVERTERS, INC. |
| K791412 | DISPOSABLE INSTRUMENT TRAY PAD | Aug 16, 1979 | Substantially Equivalent | ANAGO, INC. |
| K790547 | PRO-TAB | Apr 03, 1979 | Substantially Equivalent | PROFESSIONAL TAPE CO., INC. |
| K782144 | DISPOSABLE SURGICAL INSTRUMENT TIP | Jan 05, 1979 | Substantially Equivalent | ANAGO, INC. |
| K781699 | EAGLE PAC/VISIBLE SEAL | Oct 24, 1978 | Substantially Equivalent | AMERICAN STERILIZER CO. |
| K771124 | INSTRUMENT TRAY PAD | Oct 28, 1977 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K771123 | SURGICAL INSTRUMENT PROTECTOR | Oct 28, 1977 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K770912 | TIPROTECTOR | Jun 29, 1977 | Substantially Equivalent | TOWER PRODUCTS, INC. |
| K770590 | SURGI-KIT | Apr 14, 1977 | Substantially Equivalent | ETHOX CORP. |
| K760320 | PROTECTOR, SURGICAL INSTRUMENT | Sep 30, 1976 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
FEI Numbers
This FDA classification entry is associated with 265 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 265 registration numbers. Click on an entry to view related FDA registrations.