SONICISION CORDLESS ULTRASONIC DISSECTOR— 510(k) K141371

Substantially Equivalent

Covidien, Formerly Valleylab, A Division of Tyco H

FDA 510(k) clearance K141371 for SONICISION CORDLESS ULTRASONIC DISSECTOR, Substantially Equivalent on 2014-08-07. Applicant: Covidien, Formerly Valleylab, A Division of Tyco H.

Clearance details

Applicant
Covidien, Formerly Valleylab, A Division of Tyco H
Product code
Code LFL
Advisory panel
Unknown
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 LFL

product code LFL
Death
29
Injury
1,046
Malfunction
21,642
Total
22,717

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.