K221883

Substantially Equivalent

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant: AngioDynamics, Inc.
Product code: NEY
Advisory panel: General, Plastic Surgery
Date received: 2022-06-29
Decision date: 2023-03-07
Decision: Substantially Equivalent
Clearance type: Special
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.