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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 K242996
Device Name EndyMed PRO MAX
Applicant
Endymed Medical, Ltd.
12 Leshem St.
Caesarea,  IL 3088900
Applicant Contact Ohad Fisher
Correspondent
Endymed Medical, Ltd.
12 Leshem St.
Caesarea,  IL 3088900
Correspondent Contact Ohad Fisher
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
OUH   PBX  
Date Received09/26/2024
Decision Date 06/10/2025
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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