GAP — Suture, Nonabsorbable, Silk Class II
FDA product code GAP covers "Suture, Nonabsorbable, Silk", a Class II medical device regulated under 21 CFR 878.5030. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAP
- Device Class
- Class II
- Regulation Number
- 878.5030
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241486 | covidien | Sofsilk Coated Braided Silk Suture | December 3, 2024 |
| K222944 | safepath medical | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur | October 18, 2024 |
| K232355 | shandong haidike medical product co | Non absorbable Surgical Silk Suture | January 16, 2024 |
| K221767 | huaian seamen medical technology co | Surgical Sutures with or without Needle | July 31, 2023 |
| K180701 | safepath medical | SafePath Suturing System | June 25, 2018 |
| K172149 | m/s. meril endo surgery private limited | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl | October 20, 2017 |
| K162396 | teleflexmedical | SILK Surgical Suture | November 23, 2016 |
| K160623 | m/s. meril endo surgery private limited | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl | May 31, 2016 |
| K080684 | foosin medical supplies | WG-SURGICAL SUTURES WITH NEEDLE | June 9, 2008 |
| K071111 | arrow intl | NON-ABSORBABLE SILK SUTURE | July 17, 2007 |
| K053638 | mani | MANI NEEDLE & SUTURE PACK (SILK) | May 19, 2006 |
| K041514 | sutures india private limited | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | June 3, 2005 |
| K042282 | united medical industries co. | UNISILK | December 1, 2004 |
| K024091 | aurolab | SILK SUTURES | February 28, 2003 |
| K023029 | demetech | DEMETECH SILK NONABSORBABLE SUTURE | November 25, 2002 |
| K020901 | serral, s.a. de c.v | SERRALSILK | April 26, 2002 |
| K012124 | johnson and johnson medical (china) | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | September 19, 2001 |
| K003001 | gramsmed | GRAMS SILK NONABSORBABLE SUTURE | December 15, 2000 |
| K001184 | cp medical | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | June 23, 2000 |
| K000541 | arc medical supplies (beijing) co | SILK NONABSORBABLE SURGICAL SUTURES, USP | April 28, 2000 |