510(k) K252820

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) by Internacional Farmacéutica S.A DE C.V — Product Code GAM

K252820 is an FDA 510(k) premarket notification submitted by Internacional Farmacéutica S.A DE C.V for the device "PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)". The FDA issued a decision of Substantially Equivalent on October 3, 2025. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493.