FDA Product Code FEN: Device, Cystometric, Hydraulic
36
Total
36
Cleared
129d
Avg days
1991
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Device, Cystometric, Hydraulic Devices (Product Code FEN)
36 devices
No devices found for this product code.
About Product Code FEN - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code FEN since 1991, with 36 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.