K252820 is an FDA 510(k) clearance for the PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso). This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Internacional Farmac?utica S.A DE C.V (Lerma, MX). The FDA issued a Cleared decision on October 3, 2025, 29 days after receiving the submission on September 4, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K252820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2025 |
| Decision Date | October 03, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |