About This 510(k) Submission
K180137 is an FDA 510(k) clearance for the AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF), a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on February 15, 2018, 29 days after receiving the submission on January 17, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.