510(k) K113771
- Device
- SIGNAL GEAR URETHRAL CATHETER ELECTRODE
- Applicant
- NEUROVISION MEDICAL PRODUCTS, INC.
- 510(k) number
- K113771
- Product code
- FAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-13
- Date received
- 2011-12-22
- Regulation
- 876.1620
- Classification name
- Cystometric Gas (carbon-dioxide) On Hydraulic Device
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE VERGELY
- Address
- 2225 Sperry Ave., Suite 1000 Ventura CA US 93003 93003
FDA Registration Numbers#
- 3000296634
- 1820334
- 1825146
- 3011137372
- 2132111
- 3006849754
- 1930870
- 3011534533
- 3004365956
Source Documents#
Other 510(k) Records For Product Code FAP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
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