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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K251996
Device Name ENTire IRE System
Applicant
Entire Medical , Ltd.
11 Ha'Hoshlim St.
Herzliya,  IL 4672411
Applicant Contact Daniela Heimlich
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Glenn Stiegman
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/27/2025
Decision Date 01/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT06187194
NCT06438185
NCT06960239
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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