K190099 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch. 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 15, 2019, 52 days after receiving the submission on January 22, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K190099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | March 15, 2019 |
| Days to Decision | 52 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 |