BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider— 510(k) K193356

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K193356 for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider, Substantially Equivalent on 2020-03-02. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2019-12-04
Decision date: 2020-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.