510(k) K250371

cryoICE cryoXT cryoablation probe (cryoXT) by AtriCure, Inc. — Product Code GXH

K250371 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "cryoICE cryoXT cryoablation probe (cryoXT)". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250. AtriCure, Inc. has at least 10 other 510(k) clearances on record.