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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 K223095
Device Name Senhance Surgical System
Applicant
Asensus Surgical, Inc.
1 TW Alexander Drive, Suite 160
Durham,  NC  27703
Applicant Contact Casey Hinckley
Correspondent
Asensus Surgical, Inc.
1 TW Alexander Drive, Suite 160
Durham,  NC  27703
Correspondent Contact Casey Hinckley
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/30/2022
Decision Date 03/16/2023
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
Recalls CDRH Recalls
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