FDA Product Code FEN: Device, Cystometric, Hydraulic
Leading manufacturers include Srs Medical and C.R. Bard, Inc..
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
Cleared
Dec 21, 2021
CT3000Pro
Srs Medical
Gastroenterology & Urology
105d
Cleared
Sep 21, 1993
BARD URODYNAMIC CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
365d
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.