← Back to catalogue

AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180137

by Atricure, Inc.

Identifiers

510(k) Number
K180137 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a cryo-ablation probe used for cryosurgical procedures involving the removal of heat through cryothermal energy. It is classified as a Unit, Cryosurgical, Accessories under FDA product code GEH and regulation number 878.4350.

It is supplied as a reusable or single-use accessory (based on clearance context) and is intended for use in general and plastic surgery settings. The device received FDA 510(k) clearance (K180137) on February 15, 2018, and is manufactured by AtriCure, Inc. in Mason, Ohio.

Frequently asked questions

What is the AtriCure cryoICE cryo-ablation probe used for?

The device is used for cryosurgical procedures that remove heat through cryothermal energy, intended for use in general and plastic surgery settings as a cryosurgical accessory under FDA product code GEH.

Is the AtriCure cryoICE cryo-ablation probe reusable or single-use?

The device is supplied as either reusable or single-use depending on the clearance context, meaning its reuse status is determined by the specific authorization under which it is cleared or marketed.

What regulatory clearance does the AtriCure cryoICE cryo-ablation probe have?

The device received FDA 510(k) clearance under submission K180137 on February 15, 2018, and is classified as a Class II device under product code GEH and regulation 878.4350.

Who manufactures the AtriCure cryoICE cryo-ablation probe and where is it made?

The device is manufactured by AtriCure, Inc. in Mason, Ohio, United States, with the facility located at 7555 Innovation Way, Mason, OH 45040.

What are the specific model designations for the AtriCure cryoICE cryo-ablation probe?

The device includes two model designations: the AtriCure cryoICE cryo-ablation probe (CRYO3) and the AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF), both covered under the same FDA 510(k) clearance K180137.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cryoFORM Cryoablation Probe | Surgical Ablation | AtriCure, cryoICE Cryoablation Probes | Ablation Therapy - AtriCure, Inc., cryoICE Cryoablation Probes | Cryosurgical Treatment | AtriCure

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K180137 24 fields · synced Sep 25, 2026