Ablation systems
Temperature Sensor
A hand-held device intended to be used to monitor tissue temperature during a surgical ablation procedure (e.g., cryosurgical, microwave, or radio-frequency ablation), typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the surgical ablation system control unit. This is a single-use device.
Temperature Sensor models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FAT8000000 | Shaft Length 170 mm; Needle Gauge 14 G | Not stated | Available |
FDA clearances
- 510(k) K183213 December 2019
Procedures that use ablation systems
Frequently asked questions
What is Temperature Sensor used for?
A hand-held device intended to be used to monitor tissue temperature during a surgical ablation procedure (e.g., cryosurgical, microwave, or radio-frequency ablation), typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the surgical ablation system control unit. This is a single-use device.
Who makes Temperature Sensor?
Temperature Sensor is made by Icecure Medical Ltd. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does Temperature Sensor come in?
Sizes listed for Temperature Sensor: Shaft Length: 170 mm; Needle Gauge: 14 G. Confirm availability with the manufacturer's instructions for use.
Is Temperature Sensor MRI safe?
The FDA device database entry for Temperature Sensor does not state its MRI safety status. Check the labeling before MRI.
Is Temperature Sensor FDA cleared?
Temperature Sensor is covered by FDA submission K183213.
How do I contact a Icecure Medical Ltd sales representative?
Icecure Medical Ltd has not listed representatives on LA Vascular yet. Visit the Icecure Medical Ltd company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.