Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FDA product code FAP · 85 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.1620
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-05-23 – 2012-12-13
FAP
2012-12-13
FAP
1998-02-19
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
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FAP
1997-04-03
URODYNAMIC ANALYSIS MODULE
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FAP
1996-08-27
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
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FAP
1994-04-01
SCHUSTER DISPOSABLE BALLOON PROBE
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FAP
1993-11-18
UROLAB SPECTRUM
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FAP
1993-07-20
URO-PRO 2000
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FAP
1993-06-18
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
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FAP
1993-04-08
URODYNAMICS TUBING KITS #5161, #5150, #7170
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FAP
1993-02-05
URODYNAMIC CATHETERS
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FAP
1992-10-20
NICKI, MODEL NUMBER USD-NK-UP1
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FAP
1992-09-17
ENDOTEK ULTRA SYSTEM
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FAP
1992-09-04
LABORIE URODYNAMICS PROCESSOR
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FAP
1992-07-23
MERKUR 4000
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FAP
1992-06-02
PHOENIX 5 URODYNAMICS SYSTEM
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FAP
1992-04-10
MODEL 8100 URODYNAMICS MEASURING SYSTEM
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FAP
1992-04-10
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
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FAP
1992-04-10
IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
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FAP
1992-02-24
URETHRALPRESSURE PROFILE CATHETER
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FAP
1992-02-19
URODYNAMIC CATHETER
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FAP
1992-02-07
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
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FAP
1992-01-23
DANTEC UD 5500 MK2
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FAP
1992-01-07
PULLER OPTION FOR ETUDE(TM)
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FAP
1991-12-09
DANTEC MENUET
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FAP
1991-12-02
URODYNAMIC RECTAL BALLOON
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FAP
1991-09-23
ETUDE (MODEL NUMBERS 24A05 & 24A06)
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FAP
1991-08-15
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
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FAP
1991-06-10
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES
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FAP
1991-06-10
BROWNE MEDICAL SYSTEMS IMAGEPRO
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FAP
1991-05-15
URODYNAMIC MEASURING SYSTEM
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FAP
1991-04-02
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
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FAP
1991-04-02
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
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FAP
1991-03-19
BCI-100 FECAL INCONTINENCE SYSTEM
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FAP
1990-11-27
UROLAB JANUS
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FAP
1990-10-26
ETUDE, URODYNAMIC INVESTIGATION SYSTEM
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FAP
1990-09-14
BIOSEARCH ANAL BIOFEEDBACK DEVICE
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FAP
1990-09-13
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
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FAP
1990-06-11
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
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FAP
1990-05-03
DANTEC MENUET
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FAP
1989-12-08
RECTUM-COLON MOTILITY MONITOR
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FAP
1989-10-04
DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
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FAP
1988-08-11
SURGITEK CO2 DELIVERY SYSTEM
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FAP
1988-04-14
13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
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FAP
1988-04-14
DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
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FAP
1987-06-09
UROSCAN
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FAP
1986-12-03
SANDHILL AMS
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FAP
1986-10-28
MODEL 4-SC FOUR WAY STOPCOCK
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FAP
1986-10-24
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
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FAP
1986-10-24
MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
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FAP
1986-09-09
MODEL AS-72 ADMINISTRATION SET
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FAP
1986-09-04
MODEL RCV REFLUX CHECK VALVE
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FAP
1986-03-18
F.M. WEIST,KG (URODYNAMIC SYSTEMS)
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FAP
1986-01-10
UMS-100
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FAP
1986-01-10
LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
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FAP
1985-12-02
1351 UROFLOW AUTO START
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FAP
1985-10-17
LABORIE URODYNAMICS PROCESSOR
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FAP
1985-08-07
UROBEI STRESS INCONTINENCE MONITOR
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FAP
1985-05-17
WSP CODE 4300 DIOMASTER DIAGNOSTIC
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FAP
1985-05-17
WSP CODE 4310 STRESSCATH
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FAP
1985-05-16
WSP CODE 4301 DIOMASTER THERAPEUTIC
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FAP
1985-05-10
WSP CODE 4315 PADTEST
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FAP
1985-04-25
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
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FAP
1985-04-25
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
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FAP
1985-01-02
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
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FAP
1984-08-08
EMG MODULE, EMG1, W/OPTIONAL SPEAKER
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FAP
1984-02-21
PROFILE URODYNAMIC MONITORING SYS
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FAP
1983-11-28
LUMEN-4 URODYNAMIC CATHETER
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FAP
1983-01-07
URETHRAL PRESSURE PROFILE & TEMP. MODUL
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FAP
1982-12-13
UROCOMP REMOTE CONTROL 1804
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FAP
1982-11-30
1512M/F WIRE ELECTRODE NEEDLE SET
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FAP
1982-07-13
UROCOMP MODEL 1404
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FAP
1982-03-23
DISA WATER CYSTOMETER
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FAP
1981-08-13
LIFE-TECH #'S 1106/1156 UROLABS
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FAP
1980-11-24
ROBERTSON OBTURATION MONITOR INSUFFLA
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FAP
1980-06-17
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
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FAP
1979-12-06
BROWNE MODEL UA-6
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FAP
1979-12-06
BROWNE MODEL GD-5
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FAP
1979-12-06
BROWNE MODEL UD-4E
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FAP
1979-12-06
BROWNE MODEL UD-4D
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FAP
1979-12-06
BROWNE MODEL UD-4
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FAP
1979-06-01
BROWNE MODEL CF-1 AND CF-1G
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FAP
1979-06-01
BROWNE MODEL UD-4DE
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FAP
1979-05-14
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
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FAP
1977-10-18
UROFLOW-CYSTOMETER SYSTEM
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FAP
1977-05-23
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
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