K250371
- 510(k) number
- K250371
- Device name
- cryoICE cryoXT cryoablation probe (cryoXT)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- GXH — Device, Surgical, Cryogenic
- Decision date
- 2025-04-10
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250371.pdf
Official FDA record: K250371
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.