510(k) K100786— MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

Substantially Equivalent

Bsd Medical Corp.

Clearance details

Applicant: Bsd Medical Corp.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2010-03-19
Decision date: 2010-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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.