Panels › General, Plastic Surgery › Product code GAP · Class 2
Suture, Nonabsorbable, Silk
Regulation 878.5030
0510(k)s in 12 months (41 all time)
0recalls in 12 months (28 all time)
28recalls that name a 510(k)
Top companies in GAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 1 | 24 |
| United States Surgical, A Division of Tyco Healthc | 5 | 0 |
| Ethicon, Inc. | 0 | 3 |
| M/s. Meril Endo Surgery Private Limited. | 2 | 0 |
| Safepath Medical, Inc. | 2 | 0 |
| Surgical Specialties, Inc. | 2 | 0 |
| Advance Suture, Inc. | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| Alcon Laboratories | 1 | 0 |
| Arc Medical Supplies (Beijing) Co, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 2024 | K241486 | Sofsilk Coated Braided Silk Suture Covidien | GAP |
| Oct 18, 2024 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Pol Safepath Medical, Inc. | GAP |
| Jan 16, 2024 | K232355 | Non absorbable Surgical Silk Suture Shandong Haidike Medical Product Co., Ltd., CN | GAP |
| Jul 31, 2023 | K221767 | Surgical Sutures with or without Needle Huaian Seamen Medical Technology Co., Ltd., CN | GAP |
| Jun 25, 2018 | K180701 | SafePath Suturing System Safepath Medical, Inc. | GAP |
| Oct 20, 2017 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON X M/s. Meril Endo Surgery Private Limited., IN | GAP |
| Nov 23, 2016 | K162396 | SILK Surgical Suture Teleflexmedical, Inc. | GAP |
| May 31, 2016 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON X M/s. Meril Endo Surgery Private Limited., IN | GAP |
| Jun 9, 2008 | K080684 | WG-SURGICAL SUTURES WITH NEEDLE Foosin Medical Supplies, Inc., CN | GAP |
| Jul 17, 2007 | K071111 | NON-ABSORBABLE SILK SUTURE Arrow Intl., Inc. | GAP |
| May 19, 2006 | K053638 | MANI NEEDLE & SUTURE PACK (SILK) Mani, Inc. | GAP |
| Jun 3, 2005 | K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE Sutures India Private Limited, IN | GAP |
| Dec 1, 2004 | K042282 | UNISILK United Medical Industries Co. , Ltd., SA | GAP |
| Feb 28, 2003 | K024091 | SILK SUTURES Aurolab | GAP |
| Nov 25, 2002 | K023029 | DEMETECH SILK NONABSORBABLE SUTURE Demetech Corp. | GAP |
| Apr 26, 2002 | K020901 | SERRALSILK Serral, S.A. DE C.V. | GAP |
| Sep 19, 2001 | K012124 | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP Johnson & Johnson Medical (China) , Ltd., CN | GAP |
| Dec 15, 2000 | K003001 | GRAMS SILK NONABSORBABLE SUTURE Gramsmed, LLC | GAP |
| Jun 23, 2000 | K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP Cp Medical | GAP |
| Apr 28, 2000 | K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP Arc Medical Supplies (Beijing) Co, Ltd. | GAP |
| Feb 8, 2000 | K994177 | SUTRASILK SILK SUTURE Visionary Medical Supplies, Inc. | GAP |
| Feb 4, 2000 | K993999 | SILK Trading Consultants and Distributors Intl., Inc. | GAP |
| Apr 30, 1999 | K982853 | SILK SUTURE Davis & Geck, Inc. | GAP |
| Mar 15, 1999 | K990089 | SILKAM NONABSORBABLE SILK SURGICAL SUTURE Aesculap, Inc. | GAP |
| May 11, 1998 | K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc | GAP |
| Mar 27, 1998 | K980124 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc | GAP |
| Jan 16, 1997 | K964581 | SOFSILK United States Surgical, A Division of Tyco Healthc | GAP |
| Mar 4, 1996 | K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. | GAP |
| Dec 5, 1994 | K943627 | SURGISILK Sutures , Ltd., GB | GAP |
| Jul 26, 1994 | K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK Deknatel, Inc., CR | GAP |
| Jul 12, 1994 | K942234 | VISITEC PRECISE-POINT Visitec Co. | GAP |
| Mar 3, 1994 | K931913 | SUTURE NON-ABSORBABLE SILK Surgimetrics International, Ltd. | GAP |
| Jan 7, 1994 | K930826 | SUTURE NONABSORBABLE - SILK Surgical Specialties, Inc. | GAP |
| Jan 7, 1994 | K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES Surgical Specialties, Inc. | GAP |
| Jun 28, 1991 | K905454 | ADVANCE SUTURE NONABSORBABLE SILK SUTURE Advance Suture, Inc. | GAP |
| Feb 11, 1991 | K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. | GAP |
| Nov 14, 1990 | K904891 | NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) United States Surgical, A Division of Tyco Healthc | GAP |
| Nov 14, 1990 | K904478 | NONABSORBABLE SILK SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc | GAP |
| Feb 28, 1977 | K761199 | AIRWAY PRESSURE MONITOR Draeger Medical, Inc. | GAP |
| Sep 21, 1976 | K760650 | RETRACTOR, GERBODE STERNAL Dilling Co. | GAP |
| Aug 19, 1976 | K760158 | NEEDLES AND SUTURES, SILK & NYLON Alcon Laboratories | GAP |
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