Solero Microwave Tissue Ablation (MTA) System and Accessories— 510(k) K213067

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K213067 for Solero Microwave Tissue Ablation (MTA) System and Accessories, Substantially Equivalent on 2021-12-03. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2021-09-23
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, 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.