FDA 510(k) Applications for Medical Device Product Code "KCT"
(Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K070428 A.R. MEDICOM, INC. MEDICOM SELF-SEALING STERILIZATION POUCH 07/17/2007
K973981 ADROIT MEDICAL SYSTEMS, INC. SAFEPASS STERILIZATION POUCH 01/29/1998
K951295 ADVANCED STERILIZATION PRODUCTS STERRAD STERILIZATION POUCH 05/19/1995
K112087 ADVANCED STERILIZATION PRODUCTS TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS 10/15/2012
K163598 ADVANCED STERILIZATION PRODUCTS Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator 07/31/2017
K162815 AESCULAP, INC SterilContainer S System 07/13/2017
K073168 AESCULAP, INC. AESCULAP PRIMELINE CONTAINER LTD. 04/28/2008
K143729 AESCULAP, INC. SterilContainer S 08/18/2015
K151242 Aesculap, Inc. SterilContainer S 10/09/2015
K182032 Aesculap, Inc. SterilContainer S System 12/21/2018
K142970 AESCULAP, INC. SterilContainer S System 07/08/2015
K172850 Aesculap, Inc. SterilContainer with PrimeLine Pro Lid 11/17/2017
K112671 AESCULAP, LTD. STERILCONTAINER SYSTEM 05/04/2012
K781699 AMERICAN STERILIZER CO. EAGLE PAC/VISIBLE SEAL 10/24/1978
K110898 AMMED SURGICAL EQUIPMENT, LLC S.C.O.R.E.S. UNIT 07/26/2012
K791412 ANAGO, INC. DISPOSABLE INSTRUMENT TRAY PAD 08/16/1979
K782144 ANAGO, INC. DISPOSABLE SURGICAL INSTRUMENT TIP 01/05/1979
K160730 ANTHOGYR Instrument kits 04/27/2017
K160574 ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG K3PRO SURGICAL TRAY 12/20/2016
K940807 ASEP-PRO, INC. SEE-THRU SELF SEALING STERILIZATION POUCH 11/18/1994
K131407 BAHADIR USA CORP. BAHADIR STERILIZATION TRAYS 08/12/2014
K102146 BAHADIR USA CORP. BAHADIR STERILIZATION TRAYS 11/18/2010
K112090 BAHADIR USA CORP. BAHADIR STERILIZATION TRAYS 06/07/2012
K042062 BARD PERIPHERAL VASCULAR, INC. PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE 09/30/2004
K810469 BEACON CONVERTERS, INC. STERILEDGE SELF SEAL POUCH 06/01/1981
K980065 C/T MED SYSTEM, LTD. C/T MED-SYSTEMS CASSETTE SYSTEM 05/11/1998
K153554 CareFusion 2200 Inc Genesis Low Temperature Reusable Rigid Container System 03/21/2016
K142529 CareFusion 2200 Inc Genesis Reusable Rigid Container System 01/08/2015
K112535 CAREFUSION 2200, INC. GENESIS REUSABLE RIGID CONTAINER SYSTEM 04/27/2012
K140850 CAREFUSION 2200, INC. GENESIS REUSABLE RIGID CONTAINER SYSTEM 08/27/2014
K932056 CARL PARKER ASSOCIATES, INC. DEFEND SELF-SEALING STERILIZATION POUCH 07/13/1994
K173259 Case Medical, Inc Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories 06/13/2018
K110682 CASE MEDICAL, INC. STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS 07/01/2011
K120117 Codman & Shurtleff, Inc. CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM 04/16/2012
K092437 Codman & Shurtleff, Inc. CODMAN STERILIZATION CONTAINERS 03/25/2010
K170226 CONFORMIS, INC iTotal Family Reusable Instrument Tray 10/25/2017
K092414 CONMED CORPORATION CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM 03/10/2010
K123175 CONMED CORPORATION DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 02/21/2013
K152969 CONMED CORPORATION ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY 03/31/2016
K133116 CONMED CORPORATION VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC 03/28/2014
K090560 CONMED LINVATEC CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS 06/29/2009
K080531 CONMED LINVATEC CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY 09/05/2008
K071783 CONTAINMED, INC. VERSAPOD (TM) INSTRUMENT TRAYS 09/09/2008
K893802 COTTRELL, LTD. PROVIEW SELF-SEALING STERILIZATION POUCH 04/04/1990
K161347 COVIDIEN Signia sterilization tray 09/07/2016
K180915 Covidien Sonicision Reusable Sterilization Tray 07/17/2018
K112536 COVIDIEN SONICISION STERILIZATION TRAY 04/19/2012
K130532 COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H IDRIVE ULTRA STERILIZATION TRAY 05/30/2013
K131170 COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H SONICISION STERILIZATION TRAY 08/28/2013
K922440 COX STERILE PRODUCTS, INC. STERIKING, SEE & PEEL 09/26/1994
K941327 CROSS COUNTRY PAPER PRODUCTS CORP. CROSSTEX SELF-SEALING STERILIZATION POUCH 12/22/1994
K834558 CURRIE MEDICAL SPECIALTIES, INC. CK10000 SERIES POUCH & BAGS ETC. 09/05/1984
K953749 CURWOOD, INC. MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS 10/19/1995
K935739 CUSH MEDICAL PRODUCTS SHAVE PREP TRAY 02/09/1994
K924118 DENTAL SERVICES, INC. PROPAK 07/13/1993
K771124 DEVON INDUSTRIES, INC. INSTRUMENT TRAY PAD 10/28/1977
K760320 DEVON INDUSTRIES, INC. PROTECTOR, SURGICAL INSTRUMENT 09/30/1976
K771123 DEVON INDUSTRIES, INC. SURGICAL INSTRUMENT PROTECTOR 10/28/1977
K151594 Ellipse Technologies, Incorporated Ellipse Supplemental Instrument Trays 01/25/2016
K960738 ENGINEERED CUSTOM MFG., INC. STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) 05/06/1997
K103213 Entellus Medical, Inc. FINESS ENDOSCOPE STERILIZATION TRAY 02/02/2011
K123234 ERMIS MEDIZINTECHNIK ERMIS STERILIZATION CONTAINER SYSTEM 07/05/2013
K770590 ETHOX CORP. SURGI-KIT 04/14/1977
K091806 FXDEVICES POGO SCREW INSTRUMENTATION TRAY 02/22/2010
K953829 GS MEDICAL PACKAGING, INC. SAFE-T-SEAL 11/09/1995
K102970 GYRUS ACMI, INC. GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT 05/20/2011
K092682 GYRUS ACMI, INC. GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS 12/11/2009
K120474 GYRUS ACMI, INC. GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY 07/10/2012
K945055 HARKEN PRODUCTS, INC. HARKEN ASSURE SELF-SEAL STERILIZATION POUCH 12/14/1994
K121280 HOLOGIC, INC. MYOSURE INTRUMENT TRAY 02/08/2013
K120947 HOLOGIC, INC. THS INSTRUMENT TRAY 10/17/2012
K142519 Implant Direct Sybron Manufacturing , LLC InterActive Complete Surgical Tray 04/15/2015
K180791 Institut Straumann AG Straumann BLX Surgical Cassette 06/21/2018
K133942 INTUITIVE SURGICAL ENDOSCOPE STERILIZATION TRAY 08/01/2014
K183139 Intuitive Surgical, Inc. Endoscope Sterilization Tray 02/01/2019
K170640 Intuitive Surgical, Inc. Endoscope Sterilization Tray 09/17/2017
K151450 INTUITIVE SURGICAL, INC. Endoscope Sterilization Tray 01/12/2016
K142937 INTUITIVE SURGICAL, INC. Endoscope Sterilization Tray 02/24/2015
K180964 Intuitive Surgical, Inc. Endoscope Sterilization Tray 09/28/2018
K072211 INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS 02/28/2008
K162600 JEWEL PRECISION SHEET METAL & MACHINE, INC. Jewel Precision Reusable Rigid Sterilization Container System 12/09/2016
K171713 JJGC Industria e Comercio de Materiais Dentarios S.A. Neodent Instrument Kits 04/05/2018
K930072 JORDCO, INC. STERITUBE 06/17/1994
K090818 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS 08/18/2009
K973827 KIMBERLY-CLARK CORP. KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION 02/11/1998
K110500 MACPHERSON MEDICAL, INC. STAT-MAT MINOR 06/23/2011
K933560 MAXXIM MEDICAL BARRIER PLASTIC PACKAGING (MODIFICATION) 04/11/1994
K935755 MEDICAL DEVICE SYSTEMS, INC. THE ULTRA 05/05/1995
K891983 MEDICAL DYNAMICS, INC. CAM-WRAP(TM) NEW STERILIZATION PROCEDURE 04/19/1989
K821332 MEDICAL INDUSTRIES PACKAGING, INC. DUSTCOVERS &/OR STERILITY MAINT. COVERS 05/27/1982
K831165 MEDICAL INDUSTRIES PACKAGING, INC. DUSTCOVERS/STERILITY MAINTENANCE COVERS 05/03/1983
K830961 MEDICAL INDUSTRIES PACKAGING, INC. EASY BREATHER HEADER BAGS 04/12/1983
K832128 MEDICAL INDUSTRIES PACKAGING, INC. SELF-SEAL STERILIZATION POUCHES 08/08/1983
K972719 MEDICEL, S.A. DE C.V. CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS 02/04/1999
K993764 MEDIPACK MEDICAL PACKAGING MFG. CO. MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH 12/16/1999
K152241 Medtronic Sofamor Danek USA, Inc. Medtronic Transportation/Sterilization Cassettes 01/20/2016
K163279 Medtronic Sofamor Danek, USA, Inc. Medtronic Transportation/Sterilization Cassettes 02/23/2017
K152743 MICROLINE SURGICAL, INC. M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) 02/08/2016
K152745 MICROLINE SURGICAL, INC. ReNew Sterilization Trays(Catalog #3708 and #3709) 05/12/2016
K051157 MICROMEDICS, INC. INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS 09/01/2005
K072563 MILTEX, INC. MILTEX RIGID CONTAINER SYSTEMS 02/12/2008
K050570 MILTEX, INC. MILTEX RIGID STERILIZATION CONTAINER SYSTEM 07/25/2005
K061033 MILTEX, INC. MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) 12/12/2006
K101653 MILTEX, INC. MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES 08/02/2010
K954185 MILTEX, INC. RE-BAG MULTI-USE POUCH, LARGE & SMALL 12/04/1995
K163600 Nobel Biocare AB Kit Boxes and Kit Plates 01/22/2018
K181075 Nobel Biocare AB PureSet Tray 09/27/2018
K170939 NuVasive Specialized Orthopedics, Incorporated Supplemental Instrument Trays 08/08/2017
K143579 NuVasive, Incorporated NuVasive Sterilization Trays 08/28/2015
K122818 OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE 01/04/2013
K171692 Olympus Winter & Ibe GmbH Instrument basket, for EndoEYE 04/02/2018
K110748 OLYMPUS WINTER & IBE GMBH OLYMPUS INSTRUMENT TRAY 02/15/2012
K033222 OLYMPUS WINTER & IBE GMBH OLYMPUS STERILIZATION TRAYS 08/02/2004
K932086 ONGARD MEDDEVICE PACKAGING, INC. AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH 11/17/1994
K932088 ONGARD MEDDEVICE PACKAGING, INC. AUTOPAK STERILIZATION POUCH 11/17/1994
K173391 OsteoMed LLC OsteoMed QuickFix Hybrid MMF Sterilization Tray 05/10/2018
K141854 OSUNG MND CO., LTD INSTRUMENT CASSETTE (EFCCL1-F) 10/29/2015
K141616 OTICON MEDICAL AB STERILIZATION CASSETTE 09/23/2014
K952787 OXBORO MEDICAL INTL., INC. FOAM INSTRUMENT GUARD 12/28/1995
K953068 OXBORO MEDICAL INTL., INC. OXBORO-MEDICAL FOAM INSTRUMENT HOLDER 01/23/1996
K173615 Paragon Medical Stryker Universal Select Sterilization Tray System 04/18/2018
K152951 PARAGON MEDICAL, INC. Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray 12/28/2015
K032119 PARAGON MEDICAL, INC. PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS 10/29/2003
K152014 PMBS, LLC MTS300 Multiple Tray Sterilization System 10/20/2015
K944864 PRIMED, INC. PRIMED RIGID CONTAINER SYSTEM 12/20/1994
K891214 PRO-SAFE PROFESSIONAL LINENS, INC. DENTAL SURGICAL WRAP #3007 A,B,C 04/14/1989
K891215 PRO-SAFE PROFESSIONAL LINENS, INC. FAST WRAP #M 101 04/14/1989
K891210 PRO-SAFE PROFESSIONAL LINENS, INC. POCKETED WRAPS #3009 A,B,C 10/13/1989
K891213 PRO-SAFE PROFESSIONAL LINENS, INC. SURGICAL INSTRUMENT POUCH #M102 04/14/1989
K790547 PROFESSIONAL TAPE CO., INC. PRO-TAB 04/03/1979
K032445 PROMEDICA, INC. THE ULTRA SYSTEM 03/29/2004
K032813 PROMEDICA, INC. THE ULTRA SYSTEM SP 02/13/2004
K131455 RESTORE MEDICAL SOLUTIONS, INC. RESTORE MODULAR STERILIZATION TRAY SYSTEM 08/30/2013
K973440 REXAM MEDICAL PACKAGING, INC. REXAM FRACTURE RESISTANT POUCH 10/20/1997
K962600 REXAM MEDICAL PACKAGING, INC. REXAM SELF-SEAL TYVEK POUCH 08/09/1996
K093800 ROBINSON MEDSURG LLC ROBINSON MEDSURG QUICKSCREW RACK 06/16/2010
K934252 ROYAL PRECISION PLASTICS, INC. RPPI STERILIZATION BAGS 06/17/1994
K172292 SciCan Ltd. SALUS - Hygiene Instrument Reprocessing Container 11/24/2017
K102103 SKELETAL DYNAMICS, LLC SKELETAL DYNAMICS STERILIZATION TRAYS 12/07/2010
K091720 SKLAR CORP. SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM 04/09/2010
K102544 SMITH & NEPHEW INC., ENDOSCOPY DIV. SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY 01/05/2011
K073551 SMITH & NEPHEW INC., ENDOSCOPY DIV. SMITH & NEPHEW INSTRUMENT TRAYS 05/21/2008
K092551 SMITH & NEPHEW INC., ENDOSCOPY DIV. SMITH & NEPHEW INSTRUMENT TRAYS 09/14/2010
K121904 SMITH & NEPHEW INC., ENDOSCOPY DIVISION GYNECOLOGY STERILIZATION TRAY 03/11/2013
K090562 SMITH & NEPHEW, INC. SMITH & NEPHEW INSTRUMENT TRAYS 03/18/2009
K091627 SMITH & NEPHEW, INC. SMITH & NEPHEW INSTRUMENT TRAYS 07/02/2009
K102122 SMITH & NEPHEW, INC. SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 11/22/2010
K884041 SPARCO, INC. MASTER-GUARD 10/07/1988
K052567 STERILE CONTAINMENT TECHNOLOGY, LLC. ONE TRAY SEALED STERILIZATION CONTAINER 03/13/2006
K962545 STERILIZATION CASSETTE SYSTEMS, INC. DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE 03/07/1997
K142109 STERILUCENT, INC STERILUCENT STERILIZATION CONTAINER SYSTEM 01/20/2015
K183301 STERIS Corporation PRO-LITE Sterilization Tray 01/03/2019
K172755 Steris Corporation PRO-LITE Sterilization Trays 02/09/2018
K103226 STERIS Corporation STERILIZATION MATS 02/18/2011
K160912 STERIS CORPORATION Sterilization Tray 10/07/2016
K140494 STERIS Corporation V-PRO STERILIZATION TRAY/ STERILIZATION MAT 07/25/2014
K070769 STERIS Corporation VHP 136 TRAY 10/05/2007
K070765 STERIS Corporation VIS-U-ALL II SELF SEAL POUCH 10/12/2007
K092745 STERIS Corporation VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU 11/19/2010
K090371 STERIS Corporation VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM 05/01/2009
K171520 SteriZign Precision Technologies, LLC SteriZign Signatur Device Protection System 02/07/2018
K933729 SULTAN CHEMISTS, INC. ASSURE SELF SEALING STERILIZATION POUCH 06/21/1994
K951590 SULTAN CHEMISTS, INC. ASSURE, SELF-SEALING STERILIZATION POUCH 05/17/1995
K142630 Summit Medical Inc. Instru-Safe Instrument Protection System 12/23/2014
K151166 Summit Medical Inc. Instru-Safe Instrument Protection System 08/18/2015
K180528 Summit Medical Inc. InstruSafe(R) Sterilization Container 11/16/2018
K142768 SUMMIT MEDICAL, INC. Instru-Safe Instrument Protection System 05/29/2015
K150540 SUMMIT MEDICAL, INC. Instru-Safe Instrument Protection System 06/22/2015
K133015 SUMMIT MEDICAL, INC. INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM 03/13/2014
K140289 SUMMIT MEDICAL, INC. INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM 06/27/2014
K141513 SUMMIT MEDICAL, INC. INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM 12/15/2014
K162063 Sybron Dental Specialties Steri-Cassette and Steri-Cage Sterilization Packaging System 04/21/2017
K040223 SYMMETRY MEDICAL USA INC. POLYVAC INSTRUMENT DELIVERY SYSTEM 10/22/2004
K012105 SYMMETRY MEDICAL, INC. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 08/02/2002
K152111 SYMMETRY SURGICAL INC. Symmetry Surgical Quad-Lock Container System 04/14/2016
K130720 SYNTHES (USA) PRODUCTS LLC SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM 08/14/2014
K100887 T.A.G. MEDICAL PRODUCTS VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY 08/09/2010
K151347 THOMPSON SURGICAL INSTRUMENTS MIS Spine Frame Instrument Case 10/16/2015
K770912 TOWER PRODUCTS, INC. TIPROTECTOR 06/29/1977
K831588 TREACE MEDICAL, INC. INSTRUMENT GUARD CAPSULE 06/15/1983
K954090 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE* STERILIZATION TRAY** 11/22/1995
K953776 WIHURI OY STERIKING STERILIZATION POUCHES & ROLLS 10/12/1995
K051242 WINNER MEDICAL (USA), INC. WINNER SELF SEAL STERILIZATION POUCH 12/13/2005


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