Clearance Summary
XSense Cryoablation System with CryoProbes received FDA 510(k) clearance under submission number K260377, sponsored by IceCure Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-02-24.
- Submission: K260377
- Applicant / Sponsor: IceCure Medical , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2026-02-24
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.