K212810 is an FDA 510(k) clearance for the MONOFIX PGCL, knotless wound closure device. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Samyang Holdings Corp., Ltd. (Daedeok-Gu, KR). The FDA issued a Cleared decision on August 5, 2022, 336 days after receiving the submission on September 3, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K212810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2021 |
| Decision Date | August 05, 2022 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4493 |