FDA Product Code GBM: Catheter, Urethral
Leading manufacturers include Well Lead Medical Co., Ltd..
FDA 510(k) Cleared Catheter, Urethral Devices (Product Code GBM)
About Product Code GBM - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code GBM since 1976, with 71 receiving FDA clearance (average review time: 119 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 GBM have taken an average of 261 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
GBM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →