← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

GAT — Suture, Nonabsorbable, Synthetic, Polyethylene

DEVICE CLASS
Class II
REGULATION
21 CFR 878.5000
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K261021Winter Innovations, Inc. · 510k2026-07-01
K260775Teleflex Medical, LLC · 510k2026-05-06
K254275Threadstone, LLC · 510k2026-03-23
K254188GM Dos Reis Industria e Comercio Ltda. · 510k2026-02-19
K253145Rti Surgical, Inc. · 510k2025-10-22
K253024Riverpoint Medical · 510k2025-10-16
K252225Medacta International S.A. · 510k2025-09-12
K252201Riverpoint Medical · 510k2025-08-13

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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