K233170

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

510(k) number: K233170
Device name: 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. OH · US
Product code: GXH — Device, Surgical, Cryogenic
Decision date: 2023-10-26
Date received: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Neurology

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K233170.pdf

Official FDA record: K233170

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.