GAW · Class II · 21 CFR 878.5010

FDA Product Code GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Leading manufacturers include Shandong Haidike Medical Products Co., Ltd., Cypris Medical and Ethicon, Inc..

85
Total
85
Cleared
125d
Avg days
1990
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 130d avg (recent)

FDA 510(k) Cleared Suture, Nonabsorbable, Synthetic, Polypropylene Devices (Product Code GAW)

85 devices
1–24 of 85

About Product Code GAW - Regulatory Context

510(k) Submission Activity

85 total 510(k) submissions under product code GAW since 1990, with 85 receiving FDA clearance (average review time: 125 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA Review Time

FDA review times for GAW submissions have been consistent, averaging 130 days recently vs 125 days historically.

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