ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR— 510(k) K122762

Substantially Equivalent

Microsulis Medical Limited

FDA 510(k) clearance K122762 for ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR, Substantially Equivalent on 2012-11-30. Applicant: Microsulis Medical Limited.

Clearance details

Applicant: Microsulis Medical Limited
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2012-09-10
Decision date: 2012-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmead, GB

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.