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., Dantec Medical, Inc. and Life-Tech Instruments, 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 Jun 18, 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383
Synectics-Dantec
Gastroenterology & Urology · 297d
Cleared Sep 17, 1992
ENDOTEK ULTRA SYSTEM
K920451
Surgitek
Gastroenterology & Urology · 226d
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
Cleared Dec 02, 1991
URODYNAMIC RECTAL BALLOON
K912451
Cook Urological, Inc.
Gastroenterology & Urology · 182d
Cleared Sep 23, 1991
ETUDE (MODEL NUMBERS 24A05 & 24A06)
K913323
Dantec Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Nov 27, 1990
UROLAB JANUS
K904386
Life-Tech Intl., Inc.
Gastroenterology & Urology · 64d
Cleared Oct 26, 1990
ETUDE, URODYNAMIC INVESTIGATION SYSTEM
K901494
Dantec Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Sep 14, 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 11, 1990
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
K900494
Synectics-Dantec
Gastroenterology & Urology · 129d
Cleared May 03, 1990
DANTEC MENUET
K896575
Dantec Medical, Inc.
Gastroenterology & Urology · 164d
Cleared Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
K881736
Medical Engineering Corp.
Gastroenterology & Urology · 111d
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

About Product Code FAP - Regulatory Context