FDA Product Code FEN: Device, Cystometric, Hydraulic
Leading manufacturers include Life-Tech Intl., Inc., Rusch Intl. and Srs Medical.
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
Nov 30, 1995
PVC ABDOMINAL/RECTAL PRESSURE CATHETER
Life-Tech Intl., Inc.
Gastroenterology & Urology
76d
Cleared
Oct 17, 1995
URODYNAMICS TUBING AND INFUSION SETS
Life-Tech Intl., Inc.
Gastroenterology & Urology
29d
Cleared
Oct 05, 1995
UROPUMP TUBE & DAMPING CHAMGER
Life-Tech Intl., Inc.
Gastroenterology & Urology
79d
Cleared
Sep 08, 1995
UROVISION JANUS
Life-Tech Intl., Inc.
Gastroenterology & Urology
53d
Cleared
Jun 15, 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
Rusch Intl.
Gastroenterology & Urology
10d
Cleared
Jun 13, 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
Rusch Intl.
Gastroenterology & Urology
43d
Cleared
Feb 07, 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
Surgitek
Gastroenterology & Urology
151d
Cleared
Mar 30, 1994
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
Life-Tech Intl., Inc.
Gastroenterology & Urology
76d
Cleared
Nov 18, 1993
STAND ALONE CYSTOMETROGRAM
Medical Engineering Corp.
Gastroenterology & Urology
85d
Cleared
Nov 02, 1993
KENDALL URODYNAMIC CATHETERS
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology
113d
Cleared
Oct 08, 1993
SILICONE RECTAL BALLOON
Cook Urological, Inc.
Gastroenterology & Urology
269d
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.