FDA Product Code FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Leading manufacturers include Coloplast and Convatec Limited.
59
Total
59
Cleared
78d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
73d avg (recent)
FDA 510(k) Cleared Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) Devices (Product Code FCM)
59 devices
Cleared
Jun 06, 2025
Cure Catheter Insertion Kit (K1)
Convatec Limited
Gastroenterology & Urology
73d
Cleared
Aug 02, 2023
Self-Cath Closed System
Coloplast
Gastroenterology & Urology
224d
About Product Code FCM - Regulatory Context
510(k) Submission Activity
59 total 510(k) submissions under product code FCM since 1976, with 59 receiving FDA clearance (average review time: 78 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for FCM submissions have been consistent, averaging 73 days recently vs 78 days historically.
FCM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →