Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole— 510(k) K180752
Substantially EquivalentCorinth Medtech, Inc.
FDA 510(k) clearance K180752 for Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole, Substantially Equivalent on 2018-07-25. Applicant: Corinth Medtech, Inc..
Clearance details
- Applicant
- Corinth Medtech, Inc.
- Product code
- Code HIH
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.