Product code GAP
- Device name
- Suture, Nonabsorbable, Silk
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5030
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N11397S028 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1990-03-20 |
| N80989S005 | SILK SUTURES | Lukens Corp. | 1989-08-01 |
| N84348S006 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. | 1989-06-16 |
| N84348S004 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. | 1989-01-31 |
| N11397S027 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1988-12-28 |
| N80989S004 | SILK SUTURES | Lukens Corp. | 1988-10-07 |
| N85143S004 | SILK SURGICAL SUTURES | Sharpoint, Inc. | 1988-08-31 |
| N85143S007 | SILK SURGICAL SUTURES | Sharpoint, Inc. | 1988-07-19 |
| N84348S002 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. | 1988-07-14 |
| N84348S005 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. | 1988-04-28 |
| N85143S006 | SILK SURGICAL SUTURES | Sharpoint, Inc. | 1988-03-22 |
| N80989S003 | SILK SUTURES | Lukens Corp. | 1988-03-16 |
| N84348S003 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. | 1988-02-22 |
| N85143S005 | SILK SURGICAL SUTURES | Sharpoint, Inc. | 1987-10-13 |
| N11397S026 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1987-08-28 |
| N85143S003 | SUTURES | Sharpoint, Inc. | 1987-08-27 |
| N11397S025 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1987-06-18 |
| N84047S014 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1987-06-05 |
| N84047S013 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1987-05-27 |
| N80989S001 | SILK SUTURES | Lukens Corp. | 1987-04-24 |
| N85143S002 | SUTURES | Sharpoint, Inc. | 1987-04-03 |
| N84047S012 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1986-11-17 |
| N85143S001 | SUTURES | Sharpoint, Inc. | 1986-10-27 |
| N84047S011 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1986-09-30 |
| N84047S010 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1986-07-02 |
| N11397S024 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1986-06-20 |
| N11397S023 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1983-09-28 |
| N11397S022 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1983-06-07 |
| N11397S021 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | ETHICON, Inc. | 1983-03-15 |
| N84047S008 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. | 1983-03-02 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241486 | Sofsilk™ Coated Braided Silk Suture | Covidien | 2024-12-03 |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | 2024-10-18 |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018-06-25 |
| 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 |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016-11-23 |
| 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 |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-06-09 |
| K071111 | NON-ABSORBABLE SILK SUTURE | Arrow Intl., Inc. | 2007-07-17 |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | 2006-05-19 |
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 |
| K042282 | UNISILK | United Medical Industries Co. , Ltd. | 2004-12-01 |
| K024091 | SILK SUTURES | Aurolab | 2003-02-28 |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | 2002-11-25 |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 |
| K012124 | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | Johnson & Johnson Medical (China) , Ltd. | 2001-09-19 |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-15 |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | Cp Medical | 2000-06-23 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| K994177 | SUTRASILK SILK SUTURE | Visionary Medical Supplies, Inc. | 2000-02-08 |
| K993999 | SILK | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
| K982853 | SILK SUTURE | Davis & Geck, Inc. | 1999-04-30 |
| K990089 | SILKAM NONABSORBABLE SILK SURGICAL SUTURE | Aesculap, Inc. | 1999-03-15 |
| K981128 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-05-11 |
| K980124 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-03-27 |
| K964581 | SOFSILK | United States Surgical, A Division of Tyco Healthc | 1997-01-16 |
| K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 |
| K943627 | SURGISILK | Sutures , Ltd. | 1994-12-05 |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | Deknatel, Inc. | 1994-07-26 |
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| 07757093029564 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093029540 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093029502 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
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| 07757093028833 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093028734 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
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| 07757093028260 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
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