← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4493
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K253394ETHICON, Inc. · 510k2026-06-25
K253530Medtronic · 510k2026-05-28
K253852ETHICON, Inc. · 510k2026-02-06
K252743ETHICON, Inc. · 510k2025-12-22
K253620Gordian Surgical, Ltd. · 510k2025-12-16
K252820Internacional Farmacéutica S.A DE C.V · 510k2025-10-03
K233265Peters Surgical · 510k2024-10-11

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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