K953353 is an FDA 510(k) clearance for the UROVISION JANUS. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).
Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on September 8, 1995, 53 days after receiving the submission on July 17, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K953353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1995 |
| Decision Date | September 08, 1995 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEN — Device, Cystometric, Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |