510(k) K252820 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
| Applicant | Internacional Farmacéutica S.A DE C.V, Lerma, MX |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | Sep 4, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252820
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.