Cleared Special

AtriCure cryoICE cryoSPHERE cryoablation probe

K182565 · AtriCure, Inc. · Neurology
Nov 2018
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K182565 is an FDA 510(k) clearance for the AtriCure cryoICE cryoSPHERE cryoablation probe, 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 November 9, 2018, 52 days after receiving the submission on September 18, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number K182565 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2018
Decision Date November 09, 2018
Days to Decision 52 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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