Veloxion System— 510(k) K162979

Substantially Equivalent

Corinth Medtech, Inc.

FDA 510(k) clearance K162979 for Veloxion System, Substantially Equivalent on 2017-03-24. Applicant: Corinth Medtech, Inc..

Clearance details

Applicant: Corinth Medtech, Inc.
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 2016-10-26
Decision date: 2017-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJL

product code FJL

Death: 2
Total: 2

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.