FDA 510(k) Applications for Medical Device Product Code "GAP"
(Suture, Nonabsorbable, Silk)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990089 | AESCULAP, INC. | SILKAM NONABSORBABLE SILK SURGICAL SUTURE | 03/15/1999 |
| K000541 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. | SILK NONABSORBABLE SURGICAL SUTURES, USP | 04/28/2000 |
| K071111 | ARROW INTL., INC. | NON-ABSORBABLE SILK SUTURE | 07/17/2007 |
| K024091 | AUROLAB | SILK SUTURES | 02/28/2003 |
| K001184 | CP MEDICAL | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | 06/23/2000 |
| K982853 | DAVIS & GECK, INC. | SILK SUTURE | 04/30/1999 |
| K023029 | DEMETECH CORP. | DEMETECH SILK NONABSORBABLE SUTURE | 11/25/2002 |
| K080684 | FOOSIN MEDICAL SUPPLIES INC. | WG-SURGICAL SUTURES WITH NEEDLE | 06/09/2008 |
| K003001 | GRAMSMED LLC | GRAMS SILK NONABSORBABLE SUTURE | 12/15/2000 |
| K221767 | Huaian Seamen Medical Technology Co., LTD | Surgical Sutures with or without Needle | 07/31/2023 |
| K012124 | JOHNSON & JOHNSON MEDICAL (CHINA) LTD. | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | 09/19/2001 |
| K172149 | M/s. Meril Endo Surgery Private Limited | 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 | 10/20/2017 |
| K160623 | M/S. MERIL ENDO SURGERY PRIVATE LIMITED | 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 | 05/31/2016 |
| K053638 | MANI, INC. | MANI NEEDLE & SUTURE PACK (SILK) | 05/19/2006 |
| K960328 | R.K. MEDICAL, L.L.C. | SILK NONABSORBABLE SURGICAL SUTURES USP | 03/04/1996 |
| K180701 | SafePath Medical, Inc. | SafePath Suturing System | 06/25/2018 |
| K020901 | SERRAL, S.A. DE C.V. | SERRALSILK | 04/26/2002 |
| K041514 | SUTURES INDIA PRIVATE LIMITED | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | 06/03/2005 |
| K162396 | TELEFLEX MEDICAL, INC | SILK Surgical Suture | 11/23/2016 |
| K993999 | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. | SILK | 02/04/2000 |
| K042282 | UNITED MEDICAL INDUSTRIES CO. LTD. | UNISILK | 12/01/2004 |
| K964581 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SOFSILK | 01/16/1997 |
| K980124 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SOFSILK SUTURE | 03/27/1998 |
| K981128 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SOFSILK SUTURE | 05/11/1998 |
| K994177 | VISIONARY MEDICAL SUPPLIES, INC. | SUTRASILK SILK SUTURE | 02/08/2000 |
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