FORCETRIAD— 510(k) K102913

Substantially Equivalent

Covidien, Formerly Valleylab, A Division of Tyco H

FDA 510(k) clearance K102913 for FORCETRIAD, Substantially Equivalent on 2011-05-06. Applicant: Covidien, Formerly Valleylab, A Division of Tyco H.

Clearance details

Applicant
Covidien, Formerly Valleylab, A Division of Tyco H
Product code
Code GEI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Boulder, CO, US
Download summary PDFView 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, 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.