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

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K200061 ↗

FDA Product Code

NEY

FDA applicant

Galil Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of procedures can the HEATfx Microwave Ablation System be used for, and what are the key procedural approaches supported by this device?

  The HEATfx Microwave Ablation System is designed for percutaneous, open surgical, and laparoscopic procedures, primarily used for the coagulation and thermal destruction of soft tissue. It is authorized for general and plastic surgery applications, excluding cardiac procedures, as indicated by its regulatory classification and advisory committee designation.

• Are the needles provided with the HEATfx Microwave Ablation System single-use or reusable, and how does this impact their handling and storage?

  The HEATfx 2.1 and HEATfx 2.1 S needles are single-use components of the system. This means they must be handled with care to maintain sterility and discarded after a single use, requiring proper storage to preserve functionality until use.

• How is the sterility of the HEATfx Microwave Ablation System maintained, and what precautions should be taken during storage?

  The system includes single-use needles and thermal sensors, which must be stored under conditions that maintain sterility. The reusable console requires proper storage to ensure its functionality remains intact. Since the device is not MRI-safe, storage should also avoid exposure to MRI environments.

• What is the regulatory pathway for the HEATfx Microwave Ablation System, and how does this affect its availability in clinical settings?

  The HEATfx Microwave Ablation System has received FDA 510(k) clearance under the classification of a Class II medical device (regulation number 878.4400). This clearance confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed and used in clinical settings in the U.S. as intended for general and plastic surgery procedures.

• What are the key components of the HEATfx Microwave Ablation System, and how do they work together during a procedure?

  The system consists of a reusable console with a touchscreen interface, single-use HEATfx 2.1 and HEATfx 2.1 S needles, and a Multi-Point Thermal Sensor (MTS). The console operates at 2450 MHz to deliver microwave energy for tissue ablation, while the MTS monitors temperature in real-time to ensure precise and safe thermal destruction of soft tissue during percutaneous, open surgical, or laparoscopic procedures.