GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid Class II
FDA product code GAM covers "Suture, Absorbable, Synthetic, Polyglycolic Acid", a Class II medical device regulated under 21 CFR 878.4493. 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
- GAM
- Device Class
- Class II
- Regulation Number
- 878.4493
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253394 | ethicon | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | June 25, 2026 |
| K253530 | medtronic | Trexon Monofilament Synthetic Absorbable Suture | May 28, 2026 |
| K253852 | ethicon | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthet | February 6, 2026 |
| K252743 | ethicon | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MO | December 22, 2025 |
| K253620 | gordian surgical | TroClose 1200 | December 16, 2025 |
| K252820 | internacional farmacéutica s.a de c.v | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glyc | October 3, 2025 |
| K233265 | peters surgical | Monotime and Optime R | October 11, 2024 |
| K232372 | peters surgical | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | July 12, 2024 |
| K221527 | origami surgical | StitchKit | February 14, 2023 |
| K221744 | ethicon | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | November 15, 2022 |
| K212810 | samyang holdings corp | MONOFIX PGCL, knotless wound closure device | August 5, 2022 |
| K211792 | origami surgical | StitchKit | July 16, 2021 |
| K202950 | origami surgical | StitchKit COMBO | February 23, 2021 |
| K201996 | ethicon | Monocryl Plus Antibacterial Suture | December 21, 2020 |
| K200392 | sm eng co | REXSIN | July 7, 2020 |
| K200140 | silhouette lift | Silhouette Instalift | March 27, 2020 |
| K192580 | ethicon | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | December 18, 2019 |
| K183183 | ethicon | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Poly | June 27, 2019 |
| K183001 | foosin medical supplies inc | WEGO-PGLA RAPID | January 28, 2019 |
| K183004 | foosin medical supplies inc | WEGO-PGA RAPID | January 28, 2019 |