Data / Medical devices / Suture, Absorbable, Synthetic, Polyglycolic Acid

Suture, Absorbable, Synthetic, Polyglycolic Acid (GAM): 63 FDA-registered makers in 20 countries

63 establishments in 20 countries are registered with the FDA to make Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM, Class 2, 21 CFR 878.4493). 40 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 150 510(k) clearances under this code, the latest on September 29, 2026, and lists 35 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

GAM

Device class

2

Regulation

878.4493

Medical specialty

General, Plastic Surgery

Implant

Yes

Makers by country

Makers of Suture, Absorbable, Synthetic, Polyglycolic Acid

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated September 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.