PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)— 510(k) K252820

Substantially Equivalent

Internacional Farmacéutica S.A DE C.V

FDA 510(k) clearance K252820 for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus), Substantially Equivalent on 2025-10-03. Applicant: Internacional Farmacéutica S.A DE C.V.

Clearance details

Applicant: Internacional Farmacéutica S.A DE C.V
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2025-09-04
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Lerma, MX

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.