Signal Gear Urethral Catheter Electrode
FDA 510(k) K113771 · Neurovision Medical Products, Inc.
510(k) numberK113771
Submission
- Device name
- Signal Gear Urethral Catheter Electrode
- Applicant
- Neurovision Medical Products, Inc.
Ventura, CA, US - Received
- December 22, 2011
- Decision date
- December 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K130570 | Neurovision Medical Motion SensorBZQ · Traditional | 12/26/2013SE |
| K130806 | Neurovision Ink Printed Endotracheal Tube ElectrodePDQ · Special | 07/12/2013SE |
| K121931 | Nondisposable Stimulating InstrumentsETN · Traditional | 10/19/2012SE |
| K110989 | Neurovision Ink Printed Endotracheal Tube ElectrodeETN · Traditional | 11/03/2011SE |
| K110140 | Neurovision Nerve Locator MonitorGWF · Traditional | 09/30/2011SE |
| K110712 | Drytouch Suction Stimulator ProbeETN · Traditional | 06/28/2011SE |
| K110138 | Paired Hydrogel ElectrodeETN · Special | 04/08/2011SE |
| K102862 | Neurovision Se (Nerveana)ETN · Traditional | 12/21/2010SE |
Questions and answers
When was Signal Gear Urethral Catheter Electrode cleared by the FDA?
Signal Gear Urethral Catheter Electrode (K113771) received a 510(k) decision of Substantially Equivalent on December 13, 2012, 357 days after the submission was received.
What is the product code of K113771?
The FDA product code is FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a Class II (moderate risk) device regulated under 21 CFR 876.1620.