Cleared Traditional

cryoICE cryoXT cryoablation probe (cryoXT)

K250371 · AtriCure, Inc. · Neurology
Apr 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K250371 is an FDA 510(k) clearance for the cryoICE cryoXT cryoablation probe (cryoXT), 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 April 10, 2025, 59 days after receiving the submission on February 10, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K250371 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2025
Decision Date April 10, 2025
Days to Decision 59 days
Submission Type Traditional
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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