FDA Product Code
FDA Product Code GAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5030
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk Suture | Covidien | 2024-12-03 | Traditional | PDF ↗ |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | 2024-10-18 | Traditional | PDF ↗ |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 | Traditional | PDF ↗ |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 | Traditional | PDF ↗ |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018-06-25 | Traditional | PDF ↗ |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 | Special | PDF ↗ |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016-11-23 | Traditional | PDF ↗ |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | 2016-05-31 | Traditional | PDF ↗ |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-06-09 | Traditional | PDF ↗ |
| K071111 | NON-ABSORBABLE SILK SUTURE | Arrow Intl., Inc. | 2007-07-17 | Traditional | PDF ↗ |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | 2006-05-19 | Traditional | PDF ↗ |
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 | Traditional | PDF ↗ |
| K042282 | UNISILK | United Medical Industries Co. , Ltd. | 2004-12-01 | Traditional | PDF ↗ |
| K024091 | SILK SUTURES | Aurolab | 2003-02-28 | Traditional | PDF ↗ |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | 2002-11-25 | Traditional | PDF ↗ |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 | Traditional | PDF ↗ |
| K012124 | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | Johnson & Johnson Medical (China) , Ltd. | 2001-09-19 | Traditional | PDF ↗ |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-15 | Traditional | PDF ↗ |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | Cp Medical | 2000-06-23 | Traditional | PDF ↗ |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 | Traditional | PDF ↗ |
| K994177 | SUTRASILK SILK SUTURE | Visionary Medical Supplies, Inc. | 2000-02-08 | Traditional | PDF ↗ |
| K993999 | SILK | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K982853 | SILK SUTURE | Davis & Geck, Inc. | 1999-04-30 | Traditional | PDF ↗ |
| K990089 | SILKAM NONABSORBABLE SILK SURGICAL SUTURE | Aesculap, Inc. | 1999-03-15 | Traditional | PDF ↗ |
| K981128 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-05-11 | Traditional | PDF ↗ |
| K980124 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-03-27 | Traditional | PDF ↗ |
| K964581 | SOFSILK | United States Surgical, A Division of Tyco Healthc | 1997-01-16 | Traditional | PDF ↗ |
| K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | Traditional | PDF ↗ |
| K943627 | SURGISILK | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | Deknatel, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K942234 | VISITEC PRECISE-POINT | Visitec Co. | 1994-07-12 | Traditional | PDF ↗ |
| K931913 | SUTURE NON-ABSORBABLE SILK | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | Surgical Specialties, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930826 | SUTURE NONABSORBABLE - SILK | Surgical Specialties, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K905454 | ADVANCE SUTURE NONABSORBABLE SILK SUTURE | Advance Suture, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 | Traditional | PDF ↗ |
| K904478 | NONABSORBABLE SILK SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1990-11-14 | Traditional | PDF ↗ |
| K904891 | NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) | United States Surgical, A Division of Tyco Healthc | 1990-11-14 | Traditional | PDF ↗ |
| K761199 | AIRWAY PRESSURE MONITOR | Draeger Medical, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K760650 | RETRACTOR, GERBODE STERNAL | Dilling Co. | 1976-09-21 | Traditional | PDF ↗ |
| K760158 | NEEDLES AND SUTURES, SILK & NYLON | Alcon Laboratories | 1976-08-19 | Traditional | PDF ↗ |
Product code GAP · Class II · General, Plastic Surgery. Data: openFDA.