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510(k) K260377

XSense Cryoablation System with CryoProbes by IceCure Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2026
Date Received
February 5, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by IceCure Medical , Ltd.

  • DEN220077 — ProSense™ System (October 3, 2025)
  • K240892 — XSense Cryoablation System with Cryoprobes (June 28, 2024)
  • K183213 — IceSense 3, ProSense, MultiSense (December 20, 2019)
  • K102360 — ICESENCE 3 (November 29, 2010)

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