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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 K260653
Device Name Dexter L6 System
Applicant
Distalmotion SA
Rte. De La Corniche 3b
Epalinges,  CH 1066
Applicant Contact Caroline Bonnet
Correspondent
Distalmotion SA
Rte. De La Corniche 3b
Epalinges,  CH 1066
Correspondent Contact Caroline Bonnet
Classification Product Code
SDD  
Date Received02/27/2026
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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