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IceCure Medical , Ltd.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories1
Latest FDA decision2026-02-24
TypeNumberDevice NameCodeDateActions
510(k) K260377 XSense Cryoablation System with CryoProbesGEH2026-02-24 View
510(k) K240892 XSense Cryoablation System with CryoprobesGEH2024-06-28 View
510(k) K183213 IceSense 3, ProSense, MultiSenseGEH2019-12-20 View

Related Clinical Trials

NCT02200705Cryoablation of Low Risk Small Breast Cancer- ICE3 TrialCOMPLETEDNCT07629206Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)ACTIVE_NOT_RECRUITING
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