VALLEYLAB MICROWAVE ABLATION GENERATOR— 510(k) K072687

Substantially Equivalent

Covidien Lp, Formerly Know AS Valleylab, A Divison

FDA 510(k) clearance K072687 for VALLEYLAB MICROWAVE ABLATION GENERATOR, Substantially Equivalent on 2008-11-25. Applicant: Covidien Lp, Formerly Know AS Valleylab, A Divison.

Clearance details

Applicant: Covidien Lp, Formerly Know AS Valleylab, A Divison
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2007-09-24
Decision date: 2008-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.