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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
510(k) Number K251197
Device Name Dexter L6 System
Applicant
Distalmotion SA
Route De La Corniche 3b
Epalinges,  CH 1066
Applicant Contact Larry Carrier
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Classification Product Code
SDD  
Date Received04/17/2025
Decision Date 09/30/2025
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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