FAP · Class II · 21 CFR 876.1620

FDA Product Code FAP: Cystometric Gas (carbon-dioxide) On Hydraulic Device

Leading manufacturers include Life-Tech Intl., Inc., Biosearch Medical Products, Inc. and Cook Urological, Inc..

85
Total
85
Cleared
116d
Avg days
1977
Since

FDA 510(k) Cleared Cystometric Gas (carbon-dioxide) On Hydraulic Device Devices (Product Code FAP)

85 devices
1–24 of 85
Cleared Aug 27, 1996
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472
Rusch Intl.
Gastroenterology & Urology · 63d
Cleared Nov 18, 1993
UROLAB SPECTRUM
K931179
Life-Tech Intl., Inc.
Gastroenterology & Urology · 254d
Cleared Feb 24, 1992
URETHRALPRESSURE PROFILE CATHETER
K915484
Life-Tech Intl., Inc.
Gastroenterology & Urology · 80d
Cleared Feb 19, 1992
URODYNAMIC CATHETER
K915443
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 07, 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 171d
Cleared Dec 02, 1991
URODYNAMIC RECTAL BALLOON
K912451
Cook Urological, Inc.
Gastroenterology & Urology · 182d
Cleared Nov 27, 1990
UROLAB JANUS
K904386
Life-Tech Intl., Inc.
Gastroenterology & Urology · 64d
Cleared Sep 14, 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Oct 28, 1986
MODEL 4-SC FOUR WAY STOPCOCK
K863165
Life-Tech Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Oct 24, 1986
MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
K863167
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1986
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Sep 09, 1986
MODEL AS-72 ADMINISTRATION SET
K863169
Life-Tech Intl., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 04, 1986
MODEL RCV REFLUX CHECK VALVE
K862327
Life-Tech Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Dec 02, 1985
1351 UROFLOW AUTO START
K853936
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Apr 25, 1985
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
K850601
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Apr 25, 1985
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Jan 07, 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561
Nihon Kohden America, Inc.
Gastroenterology & Urology · 36d
Cleared Dec 13, 1982
UROCOMP REMOTE CONTROL 1804
K822916
Life-Tech Intl., Inc.
Gastroenterology & Urology · 73d
Cleared Nov 30, 1982
1512M/F WIRE ELECTRODE NEEDLE SET
K823432
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared Jul 13, 1982
UROCOMP MODEL 1404
K821939
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared May 14, 1979
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519
American Medical Systems, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 18, 1977
UROFLOW-CYSTOMETER SYSTEM
K771850
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 19d

About Product Code FAP - Regulatory Context