FDA Product Code
FDA Product Code GAQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4495
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | 2022-04-22 | Traditional | PDF ↗ |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 | Traditional | PDF ↗ |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 | Traditional | PDF ↗ |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | 2017-11-01 | Special | PDF ↗ |
| K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | Demetech Corp. | 2014-09-25 | Traditional | PDF ↗ |
| K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | Pontis Orthopaedics, LLC | 2014-05-28 | Special | PDF ↗ |
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | Core Essence Orthopaedics, LLC | 2008-12-24 | Abbreviated | PDF ↗ |
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | 2008-10-14 | Special | PDF ↗ |
| K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | 2007-02-07 | Abbreviated | PDF ↗ |
| K042606 | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2005-05-27 | Traditional | PDF ↗ |
| K041333 | SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2004-08-27 | Traditional | PDF ↗ |
| K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | 2003-09-23 | Traditional | PDF ↗ |
| K023594 | TENO FIX | Ortheon Medical, LLC | 2003-05-15 | Traditional | PDF ↗ |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Cp Medical | 2003-03-28 | Abbreviated | PDF ↗ |
| K023411 | STEELEX STERNUM SET | Aesculap, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K022777 | MANUAL TOUCHE SYSTEM | Onux Medical, Inc. | 2002-11-19 | Traditional | PDF ↗ |
| K013059 | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) | Stony Brook Surgical Innovations, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K991073 | ACIER SUTURES | Cardio Thoracic Systems | 1999-07-30 | Traditional | PDF ↗ |
| K984151 | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP | Mill Pond, Inc. | 1999-04-28 | Traditional | PDF ↗ |
| K955723 | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) | Davis & Geck, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | ETHICON, Inc. | 1995-01-09 | Traditional | PDF ↗ |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | Deknatel, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K931915 | STAINLESS STEEL SUTURE | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE | ETHICON, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE | Look, Inc. | 1993-12-23 | Traditional | PDF ↗ |
| K930992 | FLEXON AND STAINLESS STEEL SUTURES | American Cyanamid Co. | 1993-12-17 | Traditional | PDF ↗ |
| K930940 | LUKENS STAINLESS STEEL SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT | Internacional Farmaceutica, S.A. DE C.V. | 1991-12-04 | Traditional | PDF ↗ |
| K913155 | LEG URINAL | Ezmt Valve Co., Inc. | 1991-09-16 | Traditional | PDF ↗ |
| K910067 | PTI STERNAL CLOSURE WIRE SUTURE | Pioneering Technologies, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K873645 | STAINLESS 22-13-5 SUTURE WIRE | Zimmer, Inc. | 1987-11-17 | Traditional | PDF ↗ |
| K865038 | SURGISTEEL | Sutures , Ltd. | 1987-06-30 | Traditional | PDF ↗ |
Product code GAQ · Class II · General, Plastic Surgery. Data: openFDA.