K260377
- 510(k) number
- K260377
- Device name
- XSense Cryoablation System with CryoProbes
- Applicant
- IceCure Medical , Ltd. IL
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2026-02-24
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260377.pdf
Official FDA record: K260377
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.