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FDA 510(k)

XSense Cryoablation System with CryoProbes

K-Number: K260377 · 2026-02-24

ApplicantIceCure Medical , Ltd.
Decision Date2026-02-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSense Cryoablation System with CryoProbes is the device name listed in this FDA 510(k) record. The listed applicant is IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K260377. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XSense Cryoablation System with CryoProbes?

XSense Cryoablation System with CryoProbes is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is IceCure Medical , Ltd.. The 510(k) number is K260377.

When did XSense Cryoablation System with CryoProbes receive FDA 510(k) clearance?

XSense Cryoablation System with CryoProbes received FDA 510(k) clearance on 2026-02-24, under 510(k) number K260377.

Who is the listed applicant for XSense Cryoablation System with CryoProbes?

The FDA 510(k) record lists IceCure Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XSense Cryoablation System with CryoProbes?

The FDA product code for XSense Cryoablation System with CryoProbes is GEH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Other records listing IceCure Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240892XSense Cryoablation System with CryoprobesK183213IceSense 3, ProSense, MultiSense

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.K251524Dr. Yglo Skin Tag RemoverTheotclab Healthcare B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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