K162979 is an FDA 510(k) clearance for the Veloxion System, 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 review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K162979 FDA.gov |
| FDA Decision | Cleared 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 |