Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FDA product code FAP · Class II (moderate risk) · 21 CFR 876.1620 · Gastroenterology, Urology
85510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Life-Tech Intl., Inc. 14
- Browne Corp. 7
- Browne Medical Systems, Inc. 7
- Dantec Medical, Inc. 6
- Warne Surgical Products, Ltd. 4
- Dantec Electronics, Inc. 3
- Diagnostic Ultrasound Corp. 3
- Browne Medical, Inc. 2
- Synectics-Dantec 2
- Cook Urological, Inc. 2
- F.M. Wiest USA, Inc. 2
- Tridak Division of Indicon, Inc. 2
- Life-Tech Instruments, Inc. 2
- Surgitek 2
- Endotek Corp. 2
- Biosearch Medical Products, Inc. 2
- Epcom Medical Systems, Inc. 1
- Nihon Kohden America, Inc. 1
- Neurovision Medical Products Inc 1
- Kli 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113771 | Signal Gear Urethral Catheter ElectrodeFAP · Traditional | Neurovision Medical Products, Inc. | 12/13/2012SE |
| K974775 | Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeFAP · Traditional | Airtronic Services, Inc. | 02/19/1998SE |
| K963330 | Urodynamic Analysis ModuleFAP · Traditional | Synectics Medical, Inc. | 04/03/1997SE |
| K962472 | Rusch Urodynamic Rectal Balloon 2-WAY CatheterFAP · Traditional | Rusch Intl. | 08/27/1996SE |
| K931175 | Schuster Disposable Balloon ProbeFAP · Traditional | Sandhill Scientific, Inc. | 04/01/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | Life-Tech Intl., Inc. | 11/18/1993SE |
| K922476 | Uro-Pro 2000FAP · Traditional | Fiberoptic Sensor Technlogies, Inc. | 07/20/1993SE |
| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | Synectics-Dantec | 06/18/1993SE |
| K923995 | Urodynamics Tubing Kits #5161, #5150, #7170FAP · Traditional | Advanced Medical Products, Inc. | 04/08/1993SE |
| K923464 | Urodynamic CathetersFAP · Traditional | R.L. Medical Corp. | 02/05/1993SE |
| K924086 | Nicki, Model Number USD-NK-UP1FAP · Traditional | Laborie Medical Technologies, Ltd. | 10/20/1992SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | Surgitek | 09/17/1992SE |
| K920777 | Laborie Urodynamics ProcessorFAP · Traditional | R. Laborie Surgical , Ltd. | 09/04/1992SE |
| K920575 | Merkur 4000FAP · Traditional | F.M. Wiest USA, Inc. | 07/23/1992SE |
| K914300 | Phoenix 5 Urodynamics SystemFAP · Traditional | Aspen Medical , Ltd. | 06/02/1992SE |
| K921047 | Model 8100 Urodynamics Measuring SystemFAP · Traditional | Browne Medical Systems, Inc. | 04/10/1992SE |
| K920992 | Profile Plus Urodynamics Measuring Syst, ModifiedFAP · Traditional | Browne Medical Systems, Inc. | 04/10/1992SE |
| K920991 | Image Pro Urodynamics Measuring Syst, ModificationFAP · Traditional | Browne Medical Systems, Inc. | 04/10/1992SE |
| K915484 | Urethralpressure Profile CatheterFAP · Traditional | Life-Tech Intl., Inc. | 02/24/1992SE |
| K915443 | Urodynamic CatheterFAP · Traditional | Cook Urological, Inc. | 02/19/1992SE |
| K913736 | Dobbhoff Anorect Biofeed Syst Five Div Fecal ConstFAP · Traditional | Biosearch Medical Products, Inc. | 02/07/1992SE |
| K913169 | Dantec Ud 5500 MK2FAP · Traditional | Dantec Medical, Inc. | 01/23/1992SE |
| K914891 | Puller Option for Etude(Tm)FAP · Traditional | Dantec Medical, Inc. | 01/07/1992SE |
| K912701 | Dantec MenuetFAP · Traditional | Dantec Medical, Inc. | 12/09/1991SE |
| K912451 | Urodynamic Rectal BalloonFAP · Traditional | Cook Urological, Inc. | 12/02/1991SE |
| K913323 | Etude (Model Numbers 24A05 & 24A06)FAP · Traditional | Dantec Medical, Inc. | 09/23/1991SE |
| K911125 | Diagnostic Ultrasound/Uro-Gyn Ups 2020FAP · Traditional | Diagnostic Ultrasound Corp. | 08/15/1991SE |
| K911091 | Diagnostic Ultrasound/Uro-Gyn Uds 2000 SeriesFAP · Traditional | Diagnostic Ultrasound Corp. | 06/10/1991SE |
| K910444 | Browne Medical Systems ImageproFAP · Traditional | Browne Medical Systems, Inc. | 06/10/1991SE |
| K910371 | Urodynamic Measuring SystemFAP · Traditional | Browne Medical Systems, Inc. | 05/15/1991SE |
| K910285 | Browne Medical Syst.Inc Stand-Alone Water PumpFAP · Traditional | Browne Medical Systems, Inc. | 04/02/1991SE |
| K910217 | Minipro 8100 Urodynamic Measureing SystemFAP · Traditional | Browne Medical Systems, Inc. | 04/02/1991SE |
| K904646 | BCI-100 Fecal Incontinence SystemFAP · Traditional | Biocare Intl. | 03/19/1991SE |
| K904386 | Urolab JanusFAP · Traditional | Life-Tech Intl., Inc. | 11/27/1990SE |
| K901494 | Etude, Urodynamic Investigation SystemFAP · Traditional | Dantec Medical, Inc. | 10/26/1990SE |
| K902843 | Biosearch Anal Biofeedback DeviceFAP · Traditional | Biosearch Medical Products, Inc. | 09/14/1990SE |
| K902692 | Diagnostic Ultrasound/Uro-Gyn Uds 1002FAP · Traditional | Diagnostic Ultrasound Corp. | 09/13/1990SE |
| K900494 | Synectics Liberty System, PC Polygraf & PolygramFAP · Traditional | Synectics-Dantec | 06/11/1990SE |
| K896575 | Dantec MenuetFAP · Traditional | Dantec Medical, Inc. | 05/03/1990SE |
| K884920 | Rectum-Colon Motility MonitorFAP · Traditional | Multi-Spectrum Consulting, Inc. | 12/08/1989SE |
| K884915 | Dantec 22K60/61/62 Catheter Tip TransducerFAP · Traditional | Dantec Electronics, Inc. | 10/04/1989SE |
| K881736 | Surgitek CO2 Delivery SystemFAP · Traditional | Medical Engineering Corp. | 08/11/1988SE |
| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 CableFAP · Traditional | Dantec Electronics, Inc. | 04/14/1988SE |
| K874758 | Dantec 13L40 St. Marks's Pudendal ElectrodeFAP · Traditional | Dantec Electronics, Inc. | 04/14/1988SE |
| K870855 | UroscanFAP · Traditional | Endotherapeutics | 06/09/1987SE |
| K863312 | Sandhill AmsFAP · Traditional | Sandhill | 12/03/1986SE |
| K863165 | Model 4-SC Four Way StopcockFAP · Traditional | Life-Tech Intl., Inc. | 10/28/1986SE |
| K863168 | Model 1101M & 1151M Urolab Micro Urodynamic RecordFAP · Traditional | Life-Tech Intl., Inc. | 10/24/1986SE |
| K863167 | Model 1350 Urodynamic Waveform ProcessorFAP · Traditional | Life-Tech Intl., Inc. | 10/24/1986SE |
| K863169 | Model AS-72 Administration SetFAP · Traditional | Life-Tech Intl., Inc. | 09/09/1986SE |
| K862327 | Model RCV Reflux Check ValveFAP · Traditional | Life-Tech Intl., Inc. | 09/04/1986SE |
| K860571 | F.M. Weist,Kg (Urodynamic Systems)FAP · Traditional | F.M. Wiest USA, Inc. | 03/18/1986SE |
| K853683 | UMS-100FAP · Traditional | Narco Bio-Systems | 01/10/1986SE |
| K853059 | Laborie Fiberoptic Pressure Sensor & InterfaceFAP · Traditional | Tridak Division of Indicon, Inc. | 01/10/1986SE |
| K853936 | 1351 Uroflow Auto StartFAP · Traditional | Life-Tech Intl., Inc. | 12/02/1985SE |
| K852856 | Laborie Urodynamics ProcessorFAP · Traditional | Tridak Division of Indicon, Inc. | 10/17/1985SE |
| K851483 | Urobei Stress Incontinence MonitorFAP · Traditional | Browne Medical, Inc. | 08/07/1985SE |
| K850696 | WSP Code 4300 Diomaster DiagnosticFAP · Traditional | Warne Surgical Products, Ltd. | 05/17/1985SE |
| K850694 | WSP Code 4310 StresscathFAP · Traditional | Warne Surgical Products, Ltd. | 05/17/1985SE |
| K850695 | WSP Code 4301 Diomaster TherapeuticFAP · Traditional | Warne Surgical Products, Ltd. | 05/16/1985SE |
| K850693 | WSP Code 4315 PadtestFAP · Traditional | Warne Surgical Products, Ltd. | 05/10/1985SE |
| K850602 | 1870T Pressure Transducer Pre-Amplifier, 1880 WateFAP · Traditional | Life-Tech Intl., Inc. | 04/25/1985SE |
| K850601 | Model 1712 Catheter Withdrawal Sys for Urethral PRFAP · Traditional | Life-Tech Intl., Inc. | 04/25/1985SE |
| K844503 | Urostresstik Diagnostic Cystometry PackFAP · Traditional | Epcom Medical Systems, Inc. | 01/02/1985SE |
| K842124 | Emg Module, EMG1, W/Optional SpeakerFAP · Traditional | Endotek Corp. | 08/08/1984SE |
| K834503 | Profile Urodynamic Monitoring SysFAP · Traditional | Browne Medical, Inc. | 02/21/1984SE |
| K833628 | LUMEN-4 Urodynamic CatheterFAP · Traditional | Surgitek | 11/28/1983SE |
| K823561 | Urethral Pressure Profile & Temp. ModulFAP · Traditional | Nihon Kohden America, Inc. | 01/07/1983SE |
| K822916 | Urocomp Remote Control 1804FAP · Traditional | Life-Tech Intl., Inc. | 12/13/1982SE |
| K823432 | 1512M/F Wire Electrode Needle SetFAP · Traditional | Life-Tech Intl., Inc. | 11/30/1982SE |
| K821939 | Urocomp Model 1404FAP · Traditional | Life-Tech Intl., Inc. | 07/13/1982SE |
| K820144 | Disa Water CystometerFAP · Traditional | Disa Electronics | 03/23/1982SE |
| K812178 | Life-Tech #'S 1106/1156 UrolabsFAP · Traditional | Life-Tech Instruments, Inc. | 08/13/1981SE |
| K802374 | Robertson Obturation Monitor InsufflaFAP · Traditional | Endotek Corp. | 11/24/1980SE |
| K800822 | CO2 Cystoscopy/Urethroscopy ConsoleFAP · Traditional | Kli | 06/17/1980SE |
| K792094 | Browne Model UA-6FAP · Traditional | Browne Corp. | 12/06/1979SE |
| K792093 | Browne Model GD-5FAP · Traditional | Browne Corp. | 12/06/1979SE |
| K792092 | Browne Model UD-4EFAP · Traditional | Browne Corp. | 12/06/1979SE |
| K792091 | Browne Model UD-4DFAP · Traditional | Browne Corp. | 12/06/1979SE |
| K792090 | Browne Model UD-4FAP · Traditional | Browne Corp. | 12/06/1979SE |
| K790754 | Browne Model CF-1 and CF-1GFAP · Traditional | Browne Corp. | 06/01/1979SE |
| K790478 | Browne Model UD-4DEFAP · Traditional | Browne Corp. | 06/01/1979SE |
| K790519 | Ultralite Urosystem, Models GU-1 & GU-2FAP · Traditional | American Medical Systems, Inc. | 05/14/1979SE |
| K771850 | Uroflow-Cystometer SystemFAP · Traditional | Richard Wolf Medical Instruments Corp. | 10/18/1977SE |
| K770579 | Catheter, Urethral Pressure, UPE-10 & 12FAP · Traditional | Life-Tech Instruments, Inc. | 05/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1970-2021 Class II | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | Spes Medica | 04/08/2021Terminated |
| Z-1968-2021 Class II | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | Spes Medica | 04/08/2021Terminated |
| Z-1368-2018 Class II | Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal…These products contain latex, but the following statement is not included on any level of product packaging:… | Teleflex Medical Europe Ltd | 03/15/2018Terminated |