GAP
- Product code
- GAP
- Device name
- Suture, Nonabsorbable, Silk
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.5030
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 41 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241486 | 2024-12-03 | Covidien | Sofsilk Coated Braided Silk Suture | |
| K222944 | 2024-10-18 | Safepath Medical, Inc. | SafePath Sulturing System-Silk Suture, SafePath Sult… | |
| K232355 | 2024-01-16 | Shandong Haidike Medical Product Co., … | Non absorbable Surgical Silk Suture |
Official FDA classification page: GAP
Classification and pathway per current FDA publications. Data from openFDA (CC0).