K233170
- 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.