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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Modular Electromechanical Surgical System
510(k) Number K250725
Device Name Hugo™ RAS System
Applicant
Covidien, LLC
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Shriya Kafle
Correspondent
Covidien, LLC
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Tamar Jaghasbanian
Classification Product Code
SCV  
Date Received03/10/2025
Decision Date 12/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05696444
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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