K240892
- 510(k) number
- K240892
- Device name
- XSense Cryoablation System with Cryoprobes
- Applicant
- IceCure Medical , Ltd. IL
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2024-06-28
- Date received
- 2024-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240892.pdf
Official FDA record: K240892
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.