510(k) K191335— Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Substantially Equivalent

Corinth Medtech, Inc.

Clearance details

Applicant: Corinth Medtech, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-05-17
Decision date: 2019-06-06
Decision: Substantially Equivalent
Clearance type: Special
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, 2020-01-01 through 2026-04-23. 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.