cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more— 510(k) K233170

Name: FDA 510(k) clearance K233170
Creator: U.S. Food and Drug Administration
Published: 2023-10-26

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K233170 for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more, Substantially Equivalent on 2023-10-26. Applicant: AtriCure, Inc.. Device class: 2.

Clearance details

Device name as filed: cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
Applicant: AtriCure, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2023-09-27
Decision date: 2023-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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