FDA Product Code FTM: Mesh, Surgical

510(k) Submission Activity

163 total 510(k) submissions under product code FTM since 1982, with 163 receiving FDA clearance (average review time: 111 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under FTM have taken an average of 83 days to reach a decision - down from 112 days historically, suggesting improved FDA processing for this classification.