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., Browne Corp. and Browne Medical Systems, 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 Dec 13, 2012
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
K113771
Neurovision Medical Products, Inc.
Gastroenterology & Urology · 357d
Cleared Feb 19, 1998
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775
Airtronic Services, Inc.
Gastroenterology & Urology · 59d
Cleared Apr 03, 1997
URODYNAMIC ANALYSIS MODULE
K963330
Synectics Medical, Inc.
Gastroenterology & Urology · 223d
Cleared Aug 27, 1996
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472
Rusch Intl.
Gastroenterology & Urology · 63d
Cleared Apr 01, 1994
SCHUSTER DISPOSABLE BALLOON PROBE
K931175
Sandhill Scientific, Inc.
Gastroenterology & Urology · 388d
Cleared Nov 18, 1993
UROLAB SPECTRUM
K931179
Life-Tech Intl., Inc.
Gastroenterology & Urology · 254d
Cleared Jul 20, 1993
URO-PRO 2000
K922476
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 420d
Cleared Jun 18, 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383
Synectics-Dantec
Gastroenterology & Urology · 297d
Cleared Apr 08, 1993
URODYNAMICS TUBING KITS #5161, #5150, #7170
K923995
Advanced Medical Products, Inc.
Gastroenterology & Urology · 241d
Cleared Feb 05, 1993
URODYNAMIC CATHETERS
K923464
R.L. Medical Corp.
Gastroenterology & Urology · 206d
Cleared Oct 20, 1992
NICKI, MODEL NUMBER USD-NK-UP1
K924086
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 68d
Cleared Sep 17, 1992
ENDOTEK ULTRA SYSTEM
K920451
Surgitek
Gastroenterology & Urology · 226d
Cleared Sep 04, 1992
LABORIE URODYNAMICS PROCESSOR
K920777
R. Laborie Surgical , Ltd.
Gastroenterology & Urology · 197d
Cleared Jul 23, 1992
MERKUR 4000
K920575
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 167d
Cleared Jun 02, 1992
PHOENIX 5 URODYNAMICS SYSTEM
K914300
Aspen Medical , Ltd.
Gastroenterology & Urology · 251d
Cleared Apr 10, 1992
IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
K920991
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
K920992
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
MODEL 8100 URODYNAMICS MEASURING SYSTEM
K921047
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
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 Jan 23, 1992
DANTEC UD 5500 MK2
K913169
Dantec Medical, Inc.
Gastroenterology & Urology · 190d
Cleared Jan 07, 1992
PULLER OPTION FOR ETUDE(TM)
K914891
Dantec Medical, Inc.
Gastroenterology & Urology · 68d
Cleared Dec 09, 1991
DANTEC MENUET
K912701
Dantec Medical, Inc.
Gastroenterology & Urology · 173d

About Product Code FAP - Regulatory Context