K082701 is an FDA 510(k) clearance for the URONIRS, MODEL 2000. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).
Submitted by Urodynamix Technologies, Ltd. (Vancouver Bc, CA). The FDA issued a Cleared decision on December 18, 2008, 93 days after receiving the submission on September 16, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K082701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2008 |
| Decision Date | December 18, 2008 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEN — Device, Cystometric, Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |