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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090371 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM | STERIS Corporation | 2009-05-01 | Special | PDF ↗ |
| K090562 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew, Inc. | 2009-03-18 | Special | PDF ↗ |
| K071783 | VERSAPOD (TM) INSTRUMENT TRAYS | Containmed, Inc. | 2008-09-09 | Traditional | PDF ↗ |
| K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | Conmed Linvatec | 2008-09-05 | Traditional | PDF ↗ |
| K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew Inc., Endoscopy Div. | 2008-05-21 | Abbreviated | PDF ↗ |
| K073168 | AESCULAP PRIMELINE CONTAINER LTD. | Aesculap, Inc. | 2008-04-28 | Traditional | PDF ↗ |
| K072211 | INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS | Intuitive Surgical, Inc. | 2008-02-28 | Traditional | PDF ↗ |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | Miltex, Inc. | 2008-02-12 | Traditional | PDF ↗ |
| K070765 | VIS-U-ALL II SELF SEAL POUCH | STERIS Corporation | 2007-10-12 | Traditional | PDF ↗ |
| K070769 | VHP 136 TRAY | STERIS Corporation | 2007-10-05 | Traditional | PDF ↗ |
| K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | A.R. Medicom, Inc. | 2007-07-17 | Traditional | PDF ↗ |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | Miltex, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K052567 | ONE TRAY SEALED STERILIZATION CONTAINER | Sterile Containment Technology, LLC | 2006-03-13 | Traditional | PDF ↗ |
| K051242 | WINNER SELF SEAL STERILIZATION POUCH | Winner Medical (Usa), Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Micromedics, Inc. | 2005-09-01 | Traditional | PDF ↗ |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | Miltex, Inc. | 2005-07-25 | Traditional | PDF ↗ |
| K040223 | POLYVAC INSTRUMENT DELIVERY SYSTEM | Symmetry Medical USA, Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE | Bard Peripheral Vascular, Inc. | 2004-09-30 | Traditional | PDF ↗ |
| K033222 | OLYMPUS STERILIZATION TRAYS | Olympus Winter & Ibe GmbH | 2004-08-02 | Traditional | PDF ↗ |
| K032445 | THE ULTRA SYSTEM | Promedica, Inc. | 2004-03-29 | Traditional | PDF ↗ |
| K032813 | THE ULTRA SYSTEM SP | Promedica, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | Paragon Medical, Inc. | 2003-10-29 | Traditional | PDF ↗ |
| K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | Symmetry Medical, Inc. | 2002-08-02 | Traditional | PDF ↗ |
| K993764 | MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH | Medipack Medical Packaging Mfg. Co. | 1999-12-16 | Traditional | PDF ↗ |
| K972719 | CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS | Medicel, S.A. DE C.V. | 1999-02-04 | Traditional | PDF ↗ |
| K980065 | C/T MED-SYSTEMS CASSETTE SYSTEM | C/T Med System, Ltd. | 1998-05-11 | Traditional | PDF ↗ |
| K973827 | KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION | Kimberly-Clark Corp. | 1998-02-11 | Traditional | PDF ↗ |
| K973981 | SAFEPASS STERILIZATION POUCH | Adroit Medical Systems, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K973440 | REXAM FRACTURE RESISTANT POUCH | Rexam Medical Packaging, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K960738 | STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) | Engineered Custom Mfg., Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | Sterilization Cassette Systems, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962600 | REXAM SELF-SEAL TYVEK POUCH | Rexam Medical Packaging, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K953068 | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER | Oxboro Medical Intl., Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K952787 | FOAM INSTRUMENT GUARD | Oxboro Medical Intl., Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | Miltex, Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K954090 | AUTO SUTURE* STERILIZATION TRAY** | United States Surgical, A Division of Tyco Healthc | 1995-11-22 | Traditional | PDF ↗ |
| K953829 | SAFE-T-SEAL | Gs Medical Packaging, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K953749 | MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS | Curwood, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K953776 | STERIKING STERILIZATION POUCHES & ROLLS | Wihuri OY | 1995-10-12 | Traditional | PDF ↗ |
| K951295 | STERRAD STERILIZATION POUCH | Advanced Sterilization Products | 1995-05-19 | Traditional | PDF ↗ |
| K951590 | ASSURE, SELF-SEALING STERILIZATION POUCH | Sultan Chemists, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K935755 | THE ULTRA | Medical Device Systems, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | Cross Country Paper Products Corp. | 1994-12-22 | Traditional | PDF ↗ |
| K944864 | PRIMED RIGID CONTAINER SYSTEM | Primed, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K945055 | HARKEN ASSURE SELF-SEAL STERILIZATION POUCH | Harken Products, Inc. | 1994-12-14 | Traditional | PDF ↗ |
| K940807 | SEE-THRU SELF SEALING STERILIZATION POUCH | Asep-Pro, Inc. | 1994-11-18 | Traditional | PDF ↗ |
| K932086 | AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH | Ongard Meddevice Packaging, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K932088 | AUTOPAK STERILIZATION POUCH | Ongard Meddevice Packaging, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K922440 | STERIKING, SEE & PEEL | Cox Sterile Products, Inc. | 1994-09-26 | Traditional | PDF ↗ |
| K932056 | DEFEND SELF-SEALING STERILIZATION POUCH | Carl Parker Associates, Inc. | 1994-07-13 | Traditional | PDF ↗ |
| K933729 | ASSURE SELF SEALING STERILIZATION POUCH | Sultan Chemists, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K930072 | STERITUBE | Jordco, Inc. | 1994-06-17 | Traditional | PDF ↗ |
| K934252 | RPPI STERILIZATION BAGS | Royal Precision Plastics, Inc. | 1994-06-17 | Traditional | PDF ↗ |
| K933560 | BARRIER PLASTIC PACKAGING (MODIFICATION) | Maxxim Medical | 1994-04-11 | Traditional | PDF ↗ |
| K935739 | SHAVE PREP TRAY | Cush Medical Products | 1994-02-09 | Traditional | PDF ↗ |
| K924118 | PROPAK | Dental Services, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K915477 | STERILIZATION BAG, POLYESTER/WRAP | Cgs Supplies Corp. | 1992-05-08 | Traditional | PDF ↗ |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Cottrell, Ltd. | 1990-04-04 | Traditional | PDF ↗ |
| K891210 | POCKETED WRAPS #3009 A,B,C | Pro-Safe Professional Linens, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K891983 | CAM-WRAP(TM) NEW STERILIZATION PROCEDURE | Medical Dynamics, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K891213 | SURGICAL INSTRUMENT POUCH #M102 | Pro-Safe Professional Linens, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K891214 | DENTAL SURGICAL WRAP #3007 A,B,C | Pro-Safe Professional Linens, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K891215 | FAST WRAP #M 101 | Pro-Safe Professional Linens, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K884041 | MASTER-GUARD | Sparco, Inc. | 1988-10-07 | Traditional | PDF ↗ |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Keymed, Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K854063 | MICROVASIVE SILICONE SPRAY | Microvasive | 1985-10-25 | Traditional | PDF ↗ |
| K834558 | CK10000 SERIES POUCH & BAGS ETC. | Currie Medical Specialties, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K832128 | SELF-SEAL STERILIZATION POUCHES | Medical Industries Packaging, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K831588 | INSTRUMENT GUARD CAPSULE | Treace Medical, Inc. | 1983-06-15 | Traditional | PDF ↗ |
| K831165 | DUSTCOVERS/STERILITY MAINTENANCE COVERS | Medical Industries Packaging, Inc. | 1983-05-03 | Traditional | PDF ↗ |
| K830961 | EASY BREATHER HEADER BAGS | Medical Industries Packaging, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K821332 | DUSTCOVERS &/OR STERILITY MAINT. COVERS | Medical Industries Packaging, Inc. | 1982-05-27 | Traditional | PDF ↗ |
| K810469 | STERILEDGE SELF SEAL POUCH | Beacon Converters, Inc. | 1981-06-01 | Traditional | PDF ↗ |
| K791412 | DISPOSABLE INSTRUMENT TRAY PAD | Anago, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K790547 | PRO-TAB | Professional Tape Co., Inc. | 1979-04-03 | Traditional | PDF ↗ |
| K782144 | DISPOSABLE SURGICAL INSTRUMENT TIP | Anago, Inc. | 1979-01-05 | Traditional | PDF ↗ |
| K781699 | EAGLE PAC/VISIBLE SEAL | American Sterilizer Co. | 1978-10-24 | Traditional | PDF ↗ |
| K771123 | SURGICAL INSTRUMENT PROTECTOR | Devon Industries, Inc. | 1977-10-28 | Traditional | PDF ↗ |
| K771124 | INSTRUMENT TRAY PAD | Devon Industries, Inc. | 1977-10-28 | Traditional | PDF ↗ |
| K770912 | TIPROTECTOR | Tower Products, Inc. | 1977-06-29 | Traditional | PDF ↗ |
| K770590 | SURGI-KIT | Ethox Corp. | 1977-04-14 | Traditional | PDF ↗ |
| K760320 | PROTECTOR, SURGICAL INSTRUMENT | Devon Industries, Inc. | 1976-09-30 | Traditional | PDF ↗ |
Product code KCT · Class II · General Hospital. Data: openFDA.