About This 510(k) Submission
K252820 is an FDA 510(k) clearance for the PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus), 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 review panel. Regulated under 21 CFR 878.4493.