The following data is part of a premarket notification filed by Corinth Medtech, Inc. with the FDA for Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags.
| Device ID | K191335 |
| 510k Number | K191335 |
| Device Name: | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Corinth MedTech, Inc. 1601 S. De Anza Blvd, Suite 200 Cupertino, CA 95014 |
| Contact | Sandeep Saboo |
| Correspondent | Sandeep Saboo Corinth MedTech, Inc. 1601 S. De Anza Blvd, Suite 200 Cupertino, CA 95014 |
| Product Code | HIH |
| Subsequent Product Code | GEI |
| Subsequent Product Code | HIG |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-17 |
| Decision Date | 2019-06-06 |