Product code FAP— Gastroenterology, Urology
DANTEC MENUET
- Classification name
- Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 85
- First cleared
- Most recent
Market context for product code FAP
FDA has cleared devices under product code FAP between 1977 and 2012, filed by 39 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2012
- 1998
- 1997
- 1996
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code FAP
Recent clearances under product code FAP
- K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE
- K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
- K963330 — URODYNAMIC ANALYSIS MODULE
- K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
- K931175 — SCHUSTER DISPOSABLE BALLOON PROBE
- K931179 — UROLAB SPECTRUM
- K922476 — URO-PRO 2000
- K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
- K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170
- K923464 — URODYNAMIC CATHETERS
- K924086 — NICKI, MODEL NUMBER USD-NK-UP1
- K920451 — ENDOTEK ULTRA SYSTEM
- K920777 — LABORIE URODYNAMICS PROCESSOR
- K920575 — MERKUR 4000
- K914300 — PHOENIX 5 URODYNAMICS SYSTEM
- K920991 — IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
- K920992 — PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
- K921047 — MODEL 8100 URODYNAMICS MEASURING SYSTEM
- K915484 — URETHRALPRESSURE PROFILE CATHETER
- K915443 — URODYNAMIC CATHETER
- K913736 — DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
- K913169 — DANTEC UD 5500 MK2
- K914891 — PULLER OPTION FOR ETUDE(TM)
- K912701 — DANTEC MENUET
- K912451 — URODYNAMIC RECTAL BALLOON
- K913323 — ETUDE (MODEL NUMBERS 24A05 & 24A06)
- K911125 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
- K910444 — BROWNE MEDICAL SYSTEMS IMAGEPRO
- K911091 — DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES
- K910371 — URODYNAMIC MEASURING SYSTEM
- K910217 — MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
- K910285 — BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
- K904646 — BCI-100 FECAL INCONTINENCE SYSTEM
- K904386 — UROLAB JANUS
- K901494 — ETUDE, URODYNAMIC INVESTIGATION SYSTEM
- K902843 — BIOSEARCH ANAL BIOFEEDBACK DEVICE
- K902692 — DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
- K900494 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
- K896575 — DANTEC MENUET
- K884920 — RECTUM-COLON MOTILITY MONITOR
- K884915 — DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
- K881736 — SURGITEK CO2 DELIVERY SYSTEM
- K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
- K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
- K870855 — UROSCAN
- K863312 — SANDHILL AMS
- K863165 — MODEL 4-SC FOUR WAY STOPCOCK
- K863167 — MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
- K863168 — MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
- K863169 — MODEL AS-72 ADMINISTRATION SET
- K862327 — MODEL RCV REFLUX CHECK VALVE
- K860571 — F.M. WEIST,KG (URODYNAMIC SYSTEMS)
- K853059 — LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
- K853683 — UMS-100
- K853936 — 1351 UROFLOW AUTO START
- K852856 — LABORIE URODYNAMICS PROCESSOR
- K851483 — UROBEI STRESS INCONTINENCE MONITOR
- K850694 — WSP CODE 4310 STRESSCATH
- K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC
- K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC
- K850693 — WSP CODE 4315 PADTEST
- K850601 — MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
- K850602 — 1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
- K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
- K842124 — EMG MODULE, EMG1, W/OPTIONAL SPEAKER
- K834503 — PROFILE URODYNAMIC MONITORING SYS
- K833628 — LUMEN-4 URODYNAMIC CATHETER
- K823561 — URETHRAL PRESSURE PROFILE & TEMP. MODUL
- K822916 — UROCOMP REMOTE CONTROL 1804
- K823432 — 1512M/F WIRE ELECTRODE NEEDLE SET
- K821939 — UROCOMP MODEL 1404
- K820144 — DISA WATER CYSTOMETER
- K812178 — LIFE-TECH #'S 1106/1156 UROLABS
- K802374 — ROBERTSON OBTURATION MONITOR INSUFFLA
- K800822 — CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
- K792090 — BROWNE MODEL UD-4
- K792091 — BROWNE MODEL UD-4D
- K792092 — BROWNE MODEL UD-4E
- K792093 — BROWNE MODEL GD-5
- K792094 — BROWNE MODEL UA-6
- K790478 — BROWNE MODEL UD-4DE
- K790754 — BROWNE MODEL CF-1 AND CF-1G
- K790519 — ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
- K771850 — UROFLOW-CYSTOMETER SYSTEM
- K770579 — CATHETER, URETHRAL PRESSURE, UPE-10 & 12
Data sourced from openFDA. This site is unofficial and independent of the FDA.