Cleared Special

AtriCure cryoICE BOX (ACM)

K243157 · AtriCure, Inc. · Neurology
Oct 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243157 is an FDA 510(k) clearance for the AtriCure cryoICE BOX (ACM), 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 October 29, 2024, 29 days after receiving the submission on September 30, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K243157 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date October 29, 2024
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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