Ablation systems
cryoICE Cryoablation System
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.
cryoICE Cryoablation System 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 |
|---|---|---|---|
| ACM | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| ACM1 | — | Not stated | Available |
| CRYO3 | Length 10 cm | Not stated | Available |
| CRYO3 | Length 10 cm | Not stated | Available |
| CRYO3 | Length 10 cm | Not stated | Available |
| CRYOF | Length 10 cm | Not stated | Available |
| CRYOF | Length 10 cm | Not stated | Available |
| CRYOF | Length 10 cm | Not stated | Available |
FDA clearances
- 510(k) K180137 February 2018
- 510(k) K152337 March 2016
- 510(k) K142203 November 2014
- 510(k) K142441 October 2014
Procedures that use ablation systems
Frequently asked questions
What is cryoICE Cryoablation System used for?
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.
Who makes cryoICE Cryoablation System?
cryoICE Cryoablation System is made by Atricure, Inc.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does cryoICE Cryoablation System come in?
Sizes listed for cryoICE Cryoablation System: Length: 10 cm. Confirm availability with the manufacturer's instructions for use.
Is cryoICE Cryoablation System MRI safe?
The FDA device database entry for cryoICE Cryoablation System does not state its MRI safety status. Check the labeling before MRI.
Is cryoICE Cryoablation System FDA cleared?
cryoICE Cryoablation System is covered by FDA submissions K180137, K142203, K142441, K152337.
How do I contact a Atricure, Inc. sales representative?
Atricure, Inc. has not listed representatives on LA Vascular yet. Visit the Atricure, Inc. 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.