FDA Product Code
FDA Product Code KCT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6850
510(k) Clearances — 282 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2018-09-28 | Traditional | PDF ↗ |
| K181075 | PureSet Tray | Nobel Biocare AB | 2018-09-27 | Traditional | PDF ↗ |
| K180915 | Sonicision Reusable Sterilization Tray | Covidien | 2018-07-17 | Traditional | PDF ↗ |
| K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018-06-21 | Traditional | PDF ↗ |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | Case Medical, Inc. | 2018-06-13 | Traditional | PDF ↗ |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018-05-10 | Traditional | PDF ↗ |
| K173615 | Stryker Universal Select Sterilization Tray System | Paragon Medical | 2018-04-18 | Traditional | PDF ↗ |
| K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-04-05 | Traditional | PDF ↗ |
| K171692 | Instrument basket, for EndoEYE | Olympus Winter & Ibe GmbH | 2018-04-02 | Traditional | PDF ↗ |
| K172755 | PRO-LITE Sterilization Trays | STERIS Corporation | 2018-02-09 | Traditional | PDF ↗ |
| K171520 | SteriZign Signatur Device Protection System | Sterizign Precision Technologies, LLC | 2018-02-07 | Traditional | PDF ↗ |
| K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018-01-22 | Traditional | PDF ↗ |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | Scican , Ltd. | 2017-11-24 | Abbreviated | PDF ↗ |
| K172850 | SterilContainer with PrimeLine Pro Lid | Aesculap, Inc. | 2017-11-17 | Special | PDF ↗ |
| K170226 | iTotal Family Reusable Instrument Tray | Conformis, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K170640 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2017-09-17 | Traditional | PDF ↗ |
| K170939 | Supplemental Instrument Trays | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-08 | Traditional | PDF ↗ |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | Advanced Sterilization Products | 2017-07-31 | Traditional | PDF ↗ |
| K162815 | SterilContainer S System | Aesculap, Inc. | 2017-07-13 | Traditional | PDF ↗ |
| K160730 | Instrument kits | Anthogyr | 2017-04-27 | Traditional | PDF ↗ |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Sybron Dental Specialties | 2017-04-21 | Traditional | PDF ↗ |
| K163279 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2017-02-23 | Traditional | PDF ↗ |
| K160574 | K3PRO SURGICAL TRAY | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2016-12-20 | Traditional | PDF ↗ |
| K162600 | Jewel Precision Reusable Rigid Sterilization Container System | Jewel Precision Sheet Metal & Machine, Inc. | 2016-12-09 | Traditional | PDF ↗ |
| K160912 | Sterilization Tray | STERIS Corporation | 2016-10-07 | Traditional | PDF ↗ |
| K161347 | Signia sterilization tray | Covidien | 2016-09-07 | Traditional | PDF ↗ |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | Microline Surgical, Inc. | 2016-05-12 | Traditional | PDF ↗ |
| K152111 | Symmetry Surgical Quad-Lock Container System | Symmetry Surgical, Inc. | 2016-04-14 | Traditional | PDF ↗ |
| K152969 | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY | Conmed Corporation | 2016-03-31 | Traditional | PDF ↗ |
| K153554 | Genesis Low Temperature Reusable Rigid Container System | Carefusion 2200, Inc. | 2016-03-21 | Traditional | PDF ↗ |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | Microline Surgical, Inc. | 2016-02-08 | Traditional | PDF ↗ |
| K151594 | Ellipse Supplemental Instrument Trays | Ellipse Technologies, Incorporated | 2016-01-25 | Abbreviated | PDF ↗ |
| K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016-01-20 | Traditional | PDF ↗ |
| K151450 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2016-01-12 | Traditional | PDF ↗ |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray | Paragon Medical, Inc. | 2015-12-28 | Traditional | PDF ↗ |
| K141854 | INSTRUMENT CASSETTE (EFCCL1-F) | Osung Mnd Co., Ltd. | 2015-10-29 | Traditional | PDF ↗ |
| K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | 2015-10-20 | Traditional | PDF ↗ |
| K151347 | MIS Spine Frame Instrument Case | Thompson Surgical Instruments | 2015-10-16 | Traditional | PDF ↗ |
| K151242 | SterilContainer S | Aesculap, Inc. | 2015-10-09 | Traditional | PDF ↗ |
| K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | 2015-08-28 | Traditional | PDF ↗ |
| K151166 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2015-08-18 | Traditional | PDF ↗ |
| K143729 | SterilContainer S | Aesculap, Inc. | 2015-08-18 | Traditional | PDF ↗ |
| K142970 | SterilContainer S System | Aesculap, Inc. | 2015-07-08 | Traditional | PDF ↗ |
| K150540 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2015-06-22 | Traditional | PDF ↗ |
| K142768 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2015-05-29 | Traditional | PDF ↗ |
| K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015-04-15 | Traditional | PDF ↗ |
| K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2015-02-24 | Traditional | PDF ↗ |
| K142109 | STERILUCENT STERILIZATION CONTAINER SYSTEM | Sterilucent, Inc. | 2015-01-20 | Traditional | PDF ↗ |
| K142529 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K142630 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2014-12-23 | Traditional | PDF ↗ |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Summit Medical, Inc. | 2014-12-15 | Traditional | PDF ↗ |
| K141616 | STERILIZATION CASSETTE | Oticon Medical AB | 2014-09-23 | Traditional | PDF ↗ |
| K140850 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | Carefusion 2200, Inc. | 2014-08-27 | Traditional | PDF ↗ |
| K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM | Synthes (USA) Products, LLC | 2014-08-14 | Traditional | PDF ↗ |
| K131407 | BAHADIR STERILIZATION TRAYS | Bahadir USA Corp. | 2014-08-12 | Abbreviated | PDF ↗ |
| K133942 | ENDOSCOPE STERILIZATION TRAY | Intuitive Surgical | 2014-08-01 | Abbreviated | PDF ↗ |
| K140494 | V-PRO STERILIZATION TRAY/ STERILIZATION MAT | STERIS Corporation | 2014-07-25 | Traditional | PDF ↗ |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Summit Medical, Inc. | 2014-06-27 | Traditional | PDF ↗ |
| K133116 | VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC | Conmed Corporation | 2014-03-28 | Traditional | PDF ↗ |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Summit Medical, Inc. | 2014-03-13 | Traditional | PDF ↗ |
| K131455 | RESTORE MODULAR STERILIZATION TRAY SYSTEM | Restore Medical Solutions, Inc. | 2013-08-30 | Traditional | PDF ↗ |
| K131170 | SONICISION STERILIZATION TRAY | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-08-28 | Traditional | PDF ↗ |
| K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | Ermis Medizintechnik | 2013-07-05 | Traditional | PDF ↗ |
| K130532 | IDRIVE ULTRA STERILIZATION TRAY | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-05-30 | Traditional | PDF ↗ |
| K121904 | GYNECOLOGY STERILIZATION TRAY | Smith & Nephew Inc., Endoscopy Division | 2013-03-11 | Traditional | PDF ↗ |
| K123175 | DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 | Conmed Corporation | 2013-02-21 | Abbreviated | PDF ↗ |
| K121280 | MYOSURE INTRUMENT TRAY | Hologic, Inc. | 2013-02-08 | Traditional | PDF ↗ |
| K122818 | OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE | Olympus Keymed (Medical & Industrial Equipment) LT | 2013-01-04 | Traditional | PDF ↗ |
| K120947 | THS INSTRUMENT TRAY | Hologic, Inc. | 2012-10-17 | Traditional | PDF ↗ |
| K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | Advanced Sterilization Products | 2012-10-15 | Traditional | PDF ↗ |
| K110898 | S.C.O.R.E.S. UNIT | Ammed Surgical Equipment, LLC | 2012-07-26 | Traditional | PDF ↗ |
| K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY | Gyrus Acmi, Inc. | 2012-07-10 | Traditional | PDF ↗ |
| K112090 | BAHADIR STERILIZATION TRAYS | Bahadir USA Corp. | 2012-06-07 | Abbreviated | PDF ↗ |
| K112671 | STERILCONTAINER SYSTEM | Aesculap, Ltd. | 2012-05-04 | Special | PDF ↗ |
| K112535 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | Carefusion 2200, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K112536 | SONICISION STERILIZATION TRAY | Covidien | 2012-04-19 | Abbreviated | PDF ↗ |
| K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM | Codman & Shurtleff, Inc. | 2012-04-16 | Traditional | PDF ↗ |
| K110748 | OLYMPUS INSTRUMENT TRAY | Olympus Winter & Ibe GmbH | 2012-02-15 | Traditional | PDF ↗ |
| K110682 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | Case Medical, Inc. | 2011-07-01 | Traditional | PDF ↗ |
| K110500 | STAT-MAT MINOR | Macpherson Medical, Inc. | 2011-06-23 | Traditional | PDF ↗ |
| K102970 | GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT | Gyrus Acmi, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K103226 | STERILIZATION MATS | STERIS Corporation | 2011-02-18 | Traditional | PDF ↗ |
| K103213 | FINESS ENDOSCOPE STERILIZATION TRAY | Entellus Medical, Inc. | 2011-02-02 | Traditional | PDF ↗ |
| K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY | Smith & Nephew Inc., Endoscopy Div. | 2011-01-05 | Traditional | PDF ↗ |
| K102103 | SKELETAL DYNAMICS STERILIZATION TRAYS | Skeletal Dynamics, LLC | 2010-12-07 | Traditional | PDF ↗ |
| K102122 | SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 | Smith & Nephew, Inc. | 2010-11-22 | Traditional | PDF ↗ |
| K092745 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU | STERIS Corporation | 2010-11-19 | Traditional | PDF ↗ |
| K102146 | BAHADIR STERILIZATION TRAYS | Bahadir USA Corp. | 2010-11-18 | Traditional | PDF ↗ |
| K092551 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew Inc., Endoscopy Div. | 2010-09-14 | Traditional | PDF ↗ |
| K100887 | VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY | Tag Medical Products | 2010-08-09 | Traditional | PDF ↗ |
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | Miltex, Inc. | 2010-08-02 | Traditional | PDF ↗ |
| K093800 | ROBINSON MEDSURG QUICKSCREW RACK | Robinson Medsurg, LLC | 2010-06-16 | Traditional | PDF ↗ |
| K091720 | SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM | Sklar Corp. | 2010-04-09 | Traditional | PDF ↗ |
| K092437 | CODMAN STERILIZATION CONTAINERS | Codman & Shurtleff, Inc. | 2010-03-25 | Traditional | PDF ↗ |
| K092414 | CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM | Conmed Corporation | 2010-03-10 | Abbreviated | PDF ↗ |
| K091806 | POGO SCREW INSTRUMENTATION TRAY | Fxdevices | 2010-02-22 | Traditional | PDF ↗ |
| K092682 | GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS | Gyrus Acmi, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K090818 | KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS | KARL STORZ Endoscopy-America, Inc. | 2009-08-18 | Traditional | PDF ↗ |
| K091627 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew, Inc. | 2009-07-02 | Special | PDF ↗ |
| K090560 | CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS | Conmed Linvatec | 2009-06-29 | Abbreviated | PDF ↗ |
Product code KCT · Class II · General Hospital. Data: openFDA.