Cleared Special

AtriCure cryoICE cryo-ablation probe (CRYO2)

K180138 · AtriCure, Inc. · Neurology
Feb 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K180138 is an FDA 510(k) clearance for the AtriCure cryoICE cryo-ablation probe (CRYO2), a Device, Surgical, Cryogenic (Class II — Special Controls, product code GXH), 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 Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K180138 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2018
Decision Date February 15, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXH — Device, Surgical, Cryogenic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4250

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