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510(k) K240892

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2024
Date Received
April 1, 2024
Clearance Type
Traditional
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.

  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • DEN220077 — ProSense™ System (October 3, 2025)
  • K183213 — IceSense 3, ProSense, MultiSense (December 20, 2019)
  • K102360 — ICESENCE 3 (November 29, 2010)

Other clearances for product code GEH

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  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • K253348 — TargetCool-e (October 15, 2025)
  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)