510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252820Substantially Equivalent

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

Internacional Farmaceutica, S.A. de C.V., Lerma, MX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252820 is the FDA 510(k) clearance record for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus), a class II device, cleared for Internacional Farmacéutica S.A DE C.V on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 11 510(k) clearances for Internacional Farmacéutica S.A DE C.V, from to . As of , FDA records show no recalls naming K252820.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Internacional Farmacéutica S.A DE C.V Circuito De La Industria Poniente Lote 10-C Colonia Parque, Lerma, MX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260