FDA Product Code
FDA Product Code GAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5000
510(k) Clearances — 176 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091016 | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE | Surgical Devices, A Global Business Unit Covidien | 2009-05-04 | Special | PDF ↗ |
| K090128 | TAC-TITE (TM) | Core Essence Orthopaedics, Inc. | 2009-03-19 | Special | PDF ↗ |
| K082518 | DUAL NEEDLE SUTURE PASSER SYSTEM | Cayenne Medical, Inc. | 2009-01-16 | Traditional | PDF ↗ |
| K082535 | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE | Surgical Devices, A Global Business Unit Covidien | 2008-12-01 | Traditional | PDF ↗ |
| K073149 | MENISCAL CINCH | Arthrex, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K073096 | ANCHORAGE CLOSURE DEVICE | Epitek, Inc. | 2008-02-07 | Traditional | PDF ↗ |
| K073651 | NEOTRACT ANCHOR SYSTEM | Neotract, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K071796 | CAPSEW PLICATION SYSTEM | Cayenne Medical, Inc. | 2007-10-19 | Traditional | PDF ↗ |
| K072322 | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | Smith & Nephew, Inc. | 2007-09-18 | Special | PDF ↗ |
| K070253 | AXYA SUTURE WELDING SYSTEM AND KIT | Axya Medical, Inc. | 2007-07-11 | Traditional | PDF ↗ |
| K071622 | ARTHREX FIBERWIRE | Arthrex, Inc. | 2007-07-03 | Special | PDF ↗ |
| K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | Teleflexmedical, Inc. | 2007-04-02 | Special | PDF ↗ |
| K063778 | FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE | Teleflex Medical | 2007-02-09 | Abbreviated | PDF ↗ |
| K061276 | G-PROX ENDOSCOPIC GRASPER | Usgi Medical | 2006-12-06 | Traditional | PDF ↗ |
| K063194 | TUFFLEX POLYESTER SUTURE | Axya Medical, Inc. | 2006-12-04 | Special | PDF ↗ |
| K060163 | CARDIOFLON, CARDIOXYL | Peters Surgical | 2006-10-11 | Special | PDF ↗ |
| K062307 | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS | Anulex Technologies, Inc. | 2006-09-01 | Special | PDF ↗ |
| K060165 | AXYAFLEX POLYESTER SUTURE | Axya Medical, Inc. | 2006-09-01 | Traditional | PDF ↗ |
| K060367 | TENOLIG | Fournitures Hospitalieres Industrie | 2006-08-09 | Traditional | PDF ↗ |
| K061386 | ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB | Anulex Technologies, Inc. | 2006-07-05 | Traditional | PDF ↗ |
| K060721 | LARIAT LOOP APPLICATOR | Sentreheart | 2006-06-02 | Traditional | PDF ↗ |
| K053339 | ALLOFIX ANCHOR | Musculoskeletal Transplant Foundation | 2006-03-16 | Traditional | PDF ↗ |
| K050150 | MANI NEEDLE & SUTURE PACK | Mani, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K052652 | SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE | Smith & Nephew, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K041512 | NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 | Traditional | PDF ↗ |
| K042038 | MTF ALLOGRAFT ANCHOR | Musculoskeletal Transplant Foundation | 2004-12-23 | Traditional | PDF ↗ |
| K041553 | ARTHREX SUTURE GRAFTING KIT | Arthrex, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K042286 | UNIESTER C | United Medical Industries Co. , Ltd. | 2004-12-01 | Traditional | PDF ↗ |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | Opus Medical, Inc. | 2004-10-19 | Traditional | PDF ↗ |
| K041894 | ORTHOFIBER | Cp Medical | 2004-09-17 | Special | PDF ↗ |
| K041589 | ARTHREX FIBERWIRE WITH SILK | Arthrex, Inc. | 2004-08-05 | Traditional | PDF ↗ |
| K041216 | SMITH & NEPHEW ULTRABRAID SUTURE | Smith & Nephew, Inc. | 2004-06-07 | Abbreviated | PDF ↗ |
| K040789 | DURABRAID SUTURE | Smith & Nephew, Inc. | 2004-06-04 | Abbreviated | PDF ↗ |
| K040472 | FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE | Teleflex Medical | 2004-03-15 | Special | PDF ↗ |
| K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 | Lsi Solutions | 2004-03-01 | Special | PDF ↗ |
| K033718 | MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE | Arthrotek, Inc. | 2004-02-12 | Traditional | PDF ↗ |
| K033654 | FORCE FIBER | Teleflex Medical | 2004-01-15 | Traditional | PDF ↗ |
| K032245 | ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 | Arthrex, Inc. | 2004-01-14 | Traditional | PDF ↗ |
| K032901 | STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM | Stryker Endoscopy | 2003-12-02 | Abbreviated | PDF ↗ |
| K023030 | DEMETECH POLYESTER NONABSORBABLE SUTURE | Demetech Corp. | 2003-06-18 | Traditional | PDF ↗ |
| K021434 | ARTHREX FIBERWIRE IN USP SIZES | Arthrex, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K022410 | SAPH-LOOP LIGATING LOOP | Genzyme Biosurgery | 2002-08-20 | Special | PDF ↗ |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE | Genzyme Corp. | 2002-06-18 | Traditional | PDF ↗ |
| K020902 | SERRALESTER | Serral, S.A. DE C.V. | 2002-05-20 | Traditional | PDF ↗ |
| K013990 | LIFESTITCH SUTURING DEVICE | Edwards Lifesciences, LLC | 2002-02-27 | Traditional | PDF ↗ |
| K012923 | ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 | Arthrex, Inc. | 2001-10-04 | Traditional | PDF ↗ |
| K012201 | PREMICRON NONABSORBABLE PET SURGICAL SUTURE | Aesculap, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K002172 | POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) | Xiros Plc | 2001-08-28 | Traditional | PDF ↗ |
| K010673 | ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 | Arthrex, Inc. | 2001-05-14 | Traditional | PDF ↗ |
| K003590 | GRAMS POLYESTER NONABSORBABLE SUTURE | Gramsmed, LLC | 2001-03-05 | Traditional | PDF ↗ |
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 2000-11-13 | Traditional | PDF ↗ |
| K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP | Cp Medical | 2000-06-23 | Traditional | PDF ↗ |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 2000-06-12 | Traditional | PDF ↗ |
| K000540 | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | Traditional | PDF ↗ |
| K994000 | POLYESTER | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K990952 | NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES | United States Surgical, A Division of Tyco Healthc | 1999-04-01 | Traditional | PDF ↗ |
| K984550 | PRE-THREADED ENDOBUTTON | Smith & Nephew, Inc. | 1999-03-01 | Traditional | PDF ↗ |
| K990088 | SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE | Aesculap, Inc. | 1999-02-10 | Traditional | PDF ↗ |
| K972911 | AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER | United States Surgical, A Division of Tyco Healthc | 1998-04-25 | Traditional | PDF ↗ |
| K980155 | ENDOBUTTON CONTINUOUS LOOP | Smith & Nephew, Inc. | 1998-04-01 | Traditional | PDF ↗ |
| K970416 | ACUFEX DOUBLE ARMED SUTURE NEEDLE | Smith & Nephew Endoscopy, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K961925 | POLYESTER NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-07-29 | Traditional | PDF ↗ |
| K961025 | EXPANDED BODY SUTURE | Medicinelodge, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K955747 | USSC NONABSORBABLE SUTURES | United States Surgical, A Division of Tyco Healthc | 1996-02-27 | Traditional | PDF ↗ |
| K952535 | ACUFEX ENDOBUTTON TAPE | Acufex Microsurgical, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K943221 | SURGIBOND | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K943220 | SUTULENE | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K943949 | POLYVIOLENE SURGICL SUTURE | Look, Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K931916 | SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER | Surgical Specialties, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930590 | SILK SUTURES | Davis & Geck, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K926167 | POLYVIOLENE SUTURE-REVISED LABELING | Look, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930942 | LUKENS SILK SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K930591 | TI-CRON AND DACRON SUTURES | Davis & Geck, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930945 | BRAIDED POLYESTER SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K920421 | MEDSURG MARSHMALLOW TRAY | Medsurg Industries, Inc. | 1993-12-13 | Traditional | PDF ↗ |
Product code GAT · Class II · General, Plastic Surgery. Data: openFDA.