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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K260377
Device Name XSense Cryoablation System with CryoProbes
Applicant
IceCure Medical , Ltd.
7 Haeshel St.
P.O.B 3163
Caesarea,  IL 3079504
Applicant Contact Maayan Levi
Correspondent
IceCure Medical , Ltd.
7 Haeshel St.
P.O.B 3163
Caesarea,  IL 3079504
Correspondent Contact Maayan Levi
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/05/2026
Decision Date 02/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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