GAR · Class II · 21 CFR 878.5020

FDA Product Code GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Leading manufacturers include Tas Medical, Inc..

56
Total
56
Cleared
173d
Avg days
1990
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Suture, Nonabsorbable, Synthetic, Polyamide Devices (Product Code GAR)

56 devices
1–24 of 56

About Product Code GAR - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code GAR since 1990, with 56 receiving FDA clearance (average review time: 173 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

GAR devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →