K162979 is an FDA 510(k) clearance for the Veloxion System. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on March 24, 2017, 149 days after receiving the submission on October 26, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K162979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2016 |
| Decision Date | March 24, 2017 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJL - Resectoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |