510(k) K260377
K260377 is an FDA 510(k) premarket notification submitted by IceCure Medical , Ltd. for the device "XSense Cryoablation System with CryoProbes". The FDA issued a decision of Substantially Equivalent on February 24, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. IceCure Medical , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2026
- Date Received
- February 5, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type