510(k) K200061— HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

Substantially Equivalent

Galil Medical, Inc.

Clearance details

Applicant: Galil Medical, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2020-01-13
Decision date: 2020-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, 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.