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 Medical Systems, Inc. and Browne Corp..

85
Total
85
Cleared
116d
Avg days
1977
Since
85 devices
25–48 of 85
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 Aug 15, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
K911125
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 155d
Cleared Jun 10, 1991
BROWNE MEDICAL SYSTEMS IMAGEPRO
K910444
Browne Medical Systems, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 10, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES
K911091
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 90d
Cleared May 15, 1991
URODYNAMIC MEASURING SYSTEM
K910371
Browne Medical Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 02, 1991
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
K910217
Browne Medical Systems, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 02, 1991
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
K910285
Browne Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 19, 1991
BCI-100 FECAL INCONTINENCE SYSTEM
K904646
Biocare Intl.
Gastroenterology & Urology · 159d
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 Sep 13, 1990
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
K902692
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 86d
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 Dec 08, 1989
RECTUM-COLON MOTILITY MONITOR
K884920
Multi-Spectrum Consulting, Inc.
Gastroenterology & Urology · 375d
Cleared Oct 04, 1989
DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
K884915
Dantec Electronics, Inc.
Gastroenterology & Urology · 310d
Cleared Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
K881736
Medical Engineering Corp.
Gastroenterology & Urology · 111d
Cleared Apr 14, 1988
DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
K874758
Dantec Electronics, Inc.
Gastroenterology & Urology · 148d
Cleared Apr 14, 1988
13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
K874759
Dantec Electronics, Inc.
Gastroenterology & Urology · 148d
Cleared Jun 09, 1987
UROSCAN
K870855
Endotherapeutics
Gastroenterology & Urology · 98d
Cleared Dec 03, 1986
SANDHILL AMS
K863312
Sandhill
Gastroenterology & Urology · 99d
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