Product code FAP
- Device name
- Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1620
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Neurovision Medical Products, Inc. | 2012-12-13 |
| K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | Airtronic Services, Inc. | 1998-02-19 |
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | 1997-04-03 |
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | Rusch Intl. | 1996-08-27 |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | 1994-04-01 |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | 1993-11-18 |
| K922476 | URO-PRO 2000 | Fiberoptic Sensor Technlogies, Inc. | 1993-07-20 |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | 1993-06-18 |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Advanced Medical Products, Inc. | 1993-04-08 |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | 1993-02-05 |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | 1992-10-20 |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | 1992-09-17 |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | 1992-09-04 |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | 1992-07-23 |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | 1992-06-02 |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | 1992-04-10 |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | 1992-04-10 |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | 1992-04-10 |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | 1992-02-24 |
| K915443 | URODYNAMIC CATHETER | Cook Urological, Inc. | 1992-02-19 |
| K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST | Biosearch Medical Products, Inc. | 1992-02-07 |
| K913169 | DANTEC UD 5500 MK2 | Dantec Medical, Inc. | 1992-01-23 |
| K914891 | PULLER OPTION FOR ETUDE(TM) | Dantec Medical, Inc. | 1992-01-07 |
| K912701 | DANTEC MENUET | Dantec Medical, Inc. | 1991-12-09 |
| K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) | Dantec Medical, Inc. | 1991-09-23 |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Diagnostic Ultrasound Corp. | 1991-08-15 |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Browne Medical Systems, Inc. | 1991-06-10 |
| K911091 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES | Diagnostic Ultrasound Corp. | 1991-06-10 |
| K910371 | URODYNAMIC MEASURING SYSTEM | Browne Medical Systems, Inc. | 1991-05-15 |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Browne Medical Systems, Inc. | 1991-04-02 |
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| 18054655030386 | Urethral Catheter Electrode | SPES MEDICA SPA | 2025-02-24 |
| 18054655025979 | Urethral Catheter Electrode | SPES MEDICA SPA | 2021-05-24 |
| 18054655026013 | Urethral Catheter Electrode | SPES MEDICA SPA | 2021-05-24 |
| 18054655012894 | Spes Medica Pudendal Electrode | SPES MEDICA SPA | 2020-03-11 |
| 08054655012897 | Spes Medica Pudendal Electrode | SPES MEDICA SRL | 2020-03-11 |
| 00827002154292 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002171749 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002172302 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002172524 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002172586 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002173187 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002152847 | Silber | COOK INCORPORATED | 2016-09-24 |
| 00827002167803 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002154346 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002154353 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002155404 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002170438 | Joseph | COOK INCORPORATED | 2016-09-24 |
| 00827002169876 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002168909 | Dewan | COOK INCORPORATED | 2016-09-24 |
| 00827002167056 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002161696 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002158993 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002158931 | Madduri | COOK INCORPORATED | 2016-09-24 |
| 00827002158733 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002158580 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002157392 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002156036 | Cook | COOK INCORPORATED | 2016-09-24 |
| 04026704072514 | RUSCH | TELEFLEX INCORPORATED | 2016-09-16 |