FEN · Class II · 21 CFR 876.1620

FDA Product Code FEN: Device, Cystometric, Hydraulic

Leading manufacturers include Life-Tech Intl., Inc., Medamicus, Inc. and Rusch Intl..

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
1–24 of 36
Cleared Dec 21, 2021
CT3000Pro
K212830
Srs Medical
Gastroenterology & Urology · 105d
Cleared Dec 18, 2008
URONIRS, MODEL 2000
K082701
Urodynamix Technologies, Ltd.
Gastroenterology & Urology · 93d
Cleared Mar 05, 2008
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
K073552
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 78d
Cleared Feb 28, 2000
NEURO URODYNAMIC SUITE, MODEL 9032E0101
K992715
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 200d
Cleared Nov 24, 1998
IN-PROBE II URODYNAMIC SYSTEM
K983325
Influence, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 24, 1997
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K970595
Circon Video
Gastroenterology & Urology · 248d
Cleared Jun 03, 1997
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
K971911
Medamicus, Inc.
Gastroenterology & Urology · 36d
Cleared Mar 21, 1997
ELLIPSE 4
K964522
Andromeda Medizinische Systeme GmbH
Gastroenterology & Urology · 129d
Cleared Sep 16, 1996
DANTEC DUET
K960503
Dantec Medical, Inc.
Gastroenterology & Urology · 227d
Cleared Jan 18, 1996
LUMAX(MODIFICATION)
K953734
Medamicus, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 11, 1996
LUMAX (MODIFICATION)
K954093
Medamicus, Inc.
Gastroenterology & Urology · 155d
Cleared Nov 30, 1995
PVC ABDOMINAL/RECTAL PRESSURE CATHETER
K954315
Life-Tech Intl., Inc.
Gastroenterology & Urology · 76d
Cleared Oct 17, 1995
URODYNAMICS TUBING AND INFUSION SETS
K954341
Life-Tech Intl., Inc.
Gastroenterology & Urology · 29d
Cleared Oct 05, 1995
UROPUMP TUBE & DAMPING CHAMGER
K953451
Life-Tech Intl., Inc.
Gastroenterology & Urology · 79d
Cleared Sep 08, 1995
UROVISION JANUS
K953353
Life-Tech Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Jun 15, 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573
Rusch Intl.
Gastroenterology & Urology · 10d
Cleared Jun 13, 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029
Rusch Intl.
Gastroenterology & Urology · 43d
Cleared Feb 07, 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391
Surgitek
Gastroenterology & Urology · 151d
Cleared Mar 30, 1994
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203
Life-Tech Intl., Inc.
Gastroenterology & Urology · 76d
Cleared Nov 18, 1993
STAND ALONE CYSTOMETROGRAM
K934141
Medical Engineering Corp.
Gastroenterology & Urology · 85d
Cleared Nov 02, 1993
KENDALL URODYNAMIC CATHETERS
K933399
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 113d
Cleared Oct 08, 1993
SILICONE RECTAL BALLOON
K930135
Cook Urological, Inc.
Gastroenterology & Urology · 269d
Cleared Sep 21, 1993
BARD URODYNAMIC CATHETER
K924714
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.