Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform— 510(k) K181389

Substantially Equivalent

Covidien

FDA 510(k) clearance K181389 for Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform, Substantially Equivalent on 2018-06-19. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2018-05-25
Decision date: 2018-06-19
Decision: Substantially Equivalent
Clearance type: Special
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.