XSense Cryoablation System with CryoProbes— 510(k) K260377

Substantially Equivalent

IceCure Medical , Ltd.

FDA 510(k) clearance K260377 for XSense Cryoablation System with CryoProbes, Substantially Equivalent on 2026-02-24. Applicant: IceCure Medical , Ltd..

Clearance details

Applicant: IceCure Medical , Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2026-02-05
Decision date: 2026-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.