510(k) K243157

AtriCure cryoICE BOX (ACM) by AtriCure, Inc. — Product Code GXH

K243157 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriCure cryoICE BOX (ACM)". The FDA issued a decision of Substantially Equivalent on October 29, 2024. 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.