GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid Class II
FDA Device Classification
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 |
|---|
| 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 |
| K183004 | foosin medical supplies inc | WEGO-PGA RAPID | January 28, 2019 |
| K183001 | foosin medical supplies inc | WEGO-PGLA RAPID | January 28, 2019 |
| K181652 | ethicon | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | September 28, 2018 |
| K181320 | resorba medical | Caprolon | September 18, 2018 |