K260377 is an FDA 510(k) clearance for the XSense Cryoablation System with CryoProbes. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by IceCure Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 24, 2026, 19 days after receiving the submission on February 5, 2026.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K260377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2026 |
| Decision Date | February 24, 2026 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH - Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |