K113771 is an FDA 510(k) clearance for the SIGNAL GEAR URETHRAL CATHETER ELECTRODE, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on December 13, 2012, 357 days after receiving the submission on December 22, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K113771 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2011 |
| Decision Date | December 13, 2012 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |