# K200061: HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Inc.
- Decided: Jul 9, 2020 after 178 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K870028 (1987). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133821: Emprint Ablation System, Covidien, LLC (2014) Summary page 4.
- K163105: Emprint Ablation System, Covidien, LLC (2016) Summary page 4.

## Indications for use
The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings. The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K200061
Methodology: https://510kreport.com/methodology