FDA Product Code OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male
Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy
Leading manufacturers include Boston Scientific Corporation and Coloplast.
FDA 510(k) Cleared Mesh, Surgical, For Stress Urinary Incontinence, Male Devices (Product Code OTM)
About Product Code OTM - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code OTM since 2006, with 12 receiving FDA clearance (average review time: 68 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OTM have taken an average of 51 days to reach a decision - down from 70 days historically, suggesting improved FDA processing for this classification.
OTM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →