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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K233866
Device Name Senhance Surgical System
Applicant
Asensus Surgical, Inc.
1 Tw Alexander Dr. Suite 160
Durham,  NC  27703
Applicant Contact Madhuvanthi Soundirarajan
Correspondent
Asensus Surgical, Inc.
1 Tw Alexander Dr. Suite 160
Durham,  NC  27703
Correspondent Contact Madhuvanthi Soundirarajan
Regulation Number876.1500
Classification Product Code
NAY  
Date Received12/06/2023
Decision Date 07/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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