FAP · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Gastroenterology, Urology · 21 CFR 876.1620 · Class 2
Overview
| Product Code | FAP |
|---|---|
| Device Name | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device |
| Regulation | 21 CFR 876.1620 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Cleared Devices (85)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Neurovision Medical Products, Inc. | Dec 13, 2012 | SESE |
| K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | Airtronic Services, Inc. | Feb 19, 1998 | SESE |
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | Apr 3, 1997 | SESE |
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | Rusch Intl. | Aug 27, 1996 | SESE |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | Apr 1, 1994 | SESE |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | Nov 18, 1993 | SESE |
| K922476 | URO-PRO 2000 | Fiberoptic Sensor Technlogies, Inc. | Jul 20, 1993 | SESE |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | Jun 18, 1993 | SESE |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Advanced Medical Products, Inc. | Apr 8, 1993 | SESE |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | Feb 5, 1993 | SESE |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | Oct 20, 1992 | SESE |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | Sep 17, 1992 | SESE |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | Sep 4, 1992 | SESE |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | Jul 23, 1992 | SESE |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | Jun 2, 1992 | SESE |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | Feb 24, 1992 | SESE |
| K915443 | URODYNAMIC CATHETER | Cook Urological, Inc. | Feb 19, 1992 | SESE |
| K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST | Biosearch Medical Products, Inc. | Feb 7, 1992 | SESE |
| K913169 | DANTEC UD 5500 MK2 | Dantec Medical, Inc. | Jan 23, 1992 | SESE |
| K914891 | PULLER OPTION FOR ETUDE(TM) | Dantec Medical, Inc. | Jan 7, 1992 | SESE |
| K912701 | DANTEC MENUET | Dantec Medical, Inc. | Dec 9, 1991 | SESE |
| K912451 | URODYNAMIC RECTAL BALLOON | Cook Urological, Inc. | Dec 2, 1991 | SESE |
| K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) | Dantec Medical, Inc. | Sep 23, 1991 | SESE |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Diagnostic Ultrasound Corp. | Aug 15, 1991 | SESE |
| K911091 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES | Diagnostic Ultrasound Corp. | Jun 10, 1991 | SESE |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Browne Medical Systems, Inc. | Jun 10, 1991 | SESE |
| K910371 | URODYNAMIC MEASURING SYSTEM | Browne Medical Systems, Inc. | May 15, 1991 | SESE |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | Browne Medical Systems, Inc. | Apr 2, 1991 | SESE |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Browne Medical Systems, Inc. | Apr 2, 1991 | SESE |
| K904646 | BCI-100 FECAL INCONTINENCE SYSTEM | Biocare Intl. | Mar 19, 1991 | SESE |
| K904386 | UROLAB JANUS | Life-Tech Intl., Inc. | Nov 27, 1990 | SESE |
| K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM | Dantec Medical, Inc. | Oct 26, 1990 | SESE |
| K902843 | BIOSEARCH ANAL BIOFEEDBACK DEVICE | Biosearch Medical Products, Inc. | Sep 14, 1990 | SESE |
| K902692 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 | Diagnostic Ultrasound Corp. | Sep 13, 1990 | SESE |
| K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM | Synectics-Dantec | Jun 11, 1990 | SESE |
| K896575 | DANTEC MENUET | Dantec Medical, Inc. | May 3, 1990 | SESE |
| K884920 | RECTUM-COLON MOTILITY MONITOR | Multi-Spectrum Consulting, Inc. | Dec 8, 1989 | SESE |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | Dantec Electronics, Inc. | Oct 4, 1989 | SESE |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Medical Engineering Corp. | Aug 11, 1988 | SESE |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Dantec Electronics, Inc. | Apr 14, 1988 | SESE |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | Dantec Electronics, Inc. | Apr 14, 1988 | SESE |
| K870855 | UROSCAN | Endotherapeutics | Jun 9, 1987 | SESE |
| K863312 | SANDHILL AMS | Sandhill | Dec 3, 1986 | SESE |
| K863165 | MODEL 4-SC FOUR WAY STOPCOCK | Life-Tech Intl., Inc. | Oct 28, 1986 | SESE |
| K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD | Life-Tech Intl., Inc. | Oct 24, 1986 | SESE |
| K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR | Life-Tech Intl., Inc. | Oct 24, 1986 | SESE |
| K863169 | MODEL AS-72 ADMINISTRATION SET | Life-Tech Intl., Inc. | Sep 9, 1986 | SESE |
| K862327 | MODEL RCV REFLUX CHECK VALVE | Life-Tech Intl., Inc. | Sep 4, 1986 | SESE |
| K860571 | F.M. WEIST,KG (URODYNAMIC SYSTEMS) | F.M. Wiest USA, Inc. | Mar 18, 1986 | SESE |
| K853683 | UMS-100 | Narco Bio-Systems | Jan 10, 1986 | SESE |
| K853059 | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE | Tridak Division of Indicon, Inc. | Jan 10, 1986 | SESE |
| K853936 | 1351 UROFLOW AUTO START | Life-Tech Intl., Inc. | Dec 2, 1985 | SESE |
| K852856 | LABORIE URODYNAMICS PROCESSOR | Tridak Division of Indicon, Inc. | Oct 17, 1985 | SESE |
| K851483 | UROBEI STRESS INCONTINENCE MONITOR | Browne Medical, Inc. | Aug 7, 1985 | SESE |
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | Warne Surgical Products, Ltd. | May 17, 1985 | SESE |
| K850694 | WSP CODE 4310 STRESSCATH | Warne Surgical Products, Ltd. | May 17, 1985 | SESE |
| K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC | Warne Surgical Products, Ltd. | May 16, 1985 | SESE |
| K850693 | WSP CODE 4315 PADTEST | Warne Surgical Products, Ltd. | May 10, 1985 | SESE |
| K850602 | 1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE | Life-Tech Intl., Inc. | Apr 25, 1985 | SESE |
| K850601 | MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR | Life-Tech Intl., Inc. | Apr 25, 1985 | SESE |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | Epcom Medical Systems, Inc. | Jan 2, 1985 | SESE |
| K842124 | EMG MODULE, EMG1, W/OPTIONAL SPEAKER | Endotek Corp. | Aug 8, 1984 | SESE |
| K834503 | PROFILE URODYNAMIC MONITORING SYS | Browne Medical, Inc. | Feb 21, 1984 | SESE |
| K833628 | LUMEN-4 URODYNAMIC CATHETER | Surgitek | Nov 28, 1983 | SESE |
| K823561 | URETHRAL PRESSURE PROFILE & TEMP. MODUL | Nihon Kohden America, Inc. | Jan 7, 1983 | SESE |
| K822916 | UROCOMP REMOTE CONTROL 1804 | Life-Tech Intl., Inc. | Dec 13, 1982 | SESE |
| K823432 | 1512M/F WIRE ELECTRODE NEEDLE SET | Life-Tech Intl., Inc. | Nov 30, 1982 | SESE |
| K821939 | UROCOMP MODEL 1404 | Life-Tech Intl., Inc. | Jul 13, 1982 | SESE |
| K820144 | DISA WATER CYSTOMETER | Disa Electronics | Mar 23, 1982 | SESE |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Life-Tech Instruments, Inc. | Aug 13, 1981 | SESE |
| K802374 | ROBERTSON OBTURATION MONITOR INSUFFLA | Endotek Corp. | Nov 24, 1980 | SESE |
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | Kli | Jun 17, 1980 | SESE |
| K792094 | BROWNE MODEL UA-6 | Browne Corp. | Dec 6, 1979 | SESE |
| K792093 | BROWNE MODEL GD-5 | Browne Corp. | Dec 6, 1979 | SESE |
| K792092 | BROWNE MODEL UD-4E | Browne Corp. | Dec 6, 1979 | SESE |
| K792091 | BROWNE MODEL UD-4D | Browne Corp. | Dec 6, 1979 | SESE |
| K792090 | BROWNE MODEL UD-4 | Browne Corp. | Dec 6, 1979 | SESE |
| K790754 | BROWNE MODEL CF-1 AND CF-1G | Browne Corp. | Jun 1, 1979 | SESE |
| K790478 | BROWNE MODEL UD-4DE | Browne Corp. | Jun 1, 1979 | SESE |
| K790519 | ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 | American Medical Systems, Inc. | May 14, 1979 | SESE |
| K771850 | UROFLOW-CYSTOMETER SYSTEM | Richard Wolf Medical Instruments Corp. | Oct 18, 1977 | SESE |
| K770579 | CATHETER, URETHRAL PRESSURE, UPE-10 & 12 | Life-Tech Instruments, Inc. | May 23, 1977 | SESE |
Top Applicants
- Life-Tech Intl., Inc. — 14 clearances
- Browne Medical Systems, Inc. — 7 clearances
- Browne Corp. — 7 clearances
- Dantec Medical, Inc. — 6 clearances
- Warne Surgical Products, Ltd. — 4 clearances
