510(k) K162449— Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

Substantially Equivalent

AngioDynamics, Inc.

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2016-09-01
Decision date: 2017-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, 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.