K191335 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 6, 2019, 20 days after receiving the submission on May 17, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K191335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2019 |
| Decision Date | June 06, 2019 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |