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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 K240892
Device Name XSense Cryoablation System with Cryoprobes
Applicant
IceCure Medical , Ltd.
7 Haeshel St.
P.O. Box 3163
Caesarea,  IL 3079504,
Applicant Contact Maayan Levi
Correspondent
IceCure Medical , Ltd.
7 Haeshel St.
P.O. Box 3163
Caesarea,  IL 3079504,
Correspondent Contact Maayan Levi
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/01/2024
Decision Date 06/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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