The following data is part of a premarket notification filed by Corinth Medtech, Inc. with the FDA for Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole.
| Device ID | K180752 |
| 510k Number | K180752 |
| Device Name: | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Corinth MedTech, Inc. 1601 S. De Anza Blvd, Suite 221 Cupertino, CA 95014 |
| Contact | Sandeep Saboo |
| Correspondent | Sandeep Saboo Corinth MedTech, Inc. 1601 S. De Anza Blvd, Suite 221 Cupertino, CA 95014 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-07-25 |
| Summary: | summary |