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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 a medical device manufactured by IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under approval 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. It is manufactured by IceCure Medical , Ltd.. The 510(k) number is K260377.

When was XSense Cryoablation System with CryoProbes approved by the FDA?

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

What company makes XSense Cryoablation System with CryoProbes?

XSense Cryoablation System with CryoProbes is manufactured by IceCure Medical , Ltd..

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

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT04061603 iCLAS™ for Persistent Atrial Fibrillation COMPLETED NCT05416086 iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study TERMINATED NCT06384599 VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study NOT_YET_RECRUITING NCT05675865 Cryoablation for Monomorphic Ventricular Tachycardia RECRUITING

Other Devices by IceCure Medical , Ltd.

K183213IceSense 3, ProSense, MultiSense K240892XSense Cryoablation System with Cryoprobes

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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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