GAM
- Product code
- GAM
- Device name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4493
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 149 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253394 | 2026-06-25 | ETHICON, Inc. | Coated VICRYL (Polyglactin 910) Plus Antibacterial … | |
| K253530 | 2026-05-28 | Medtronic | Trexon Monofilament Synthetic Absorbable Suture | |
| K253852 | 2026-02-06 | ETHICON, Inc. | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Mo… | FDA |
| K252743 | 2025-12-22 | ETHICON, Inc. | STRATAFIX Spiral PDS Plus Knotless Tissue Control … | |
| K253620 | 2025-12-16 | Gordian Surgical, Ltd. | TroClose 1200 | |
| K252820 | 2025-10-03 | Internacional Farmacéutica S.A DE C.V | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures… | |
| K233265 | 2024-10-11 | Peters Surgical | Monotime and Optime R | FDA |
| K232372 | 2024-07-12 | Peters Surgical | Peters Surgical ADVANTIME Absorbable Suture (ADVANTI… | FDA |
Official FDA classification page: GAM
Classification and pathway per current FDA publications. Data from openFDA (CC0).