DeviceClearance

K190113

Substantially Equivalent

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant
Corinth Medtech, Inc.
Product code
HIH
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cupertino, CA, US
Download summary PDF View on FDA.gov ↗

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.