Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode— 510(k) K151976

Substantially Equivalent

Omnitech Systems, Inc.

FDA 510(k) clearance K151976 for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode, Substantially Equivalent on 2016-06-27. Applicant: Omnitech Systems, Inc..

Clearance details

Applicant: Omnitech Systems, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2015-07-16
Decision date: 2016-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valparaiso, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.