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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 K171120
Device Name Senhance Surgical Robotic System
Applicant
TransEnterix, Inc.
635 Davis Drive, Suite 300
Morrisville,  NC  27560
Applicant Contact Stephanie Fitts
Correspondent
TransEnterix, Inc.
635 Davis Drive, Suite 300
Morrisville,  NC  27560
Correspondent Contact Stephanie Fitts
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received04/14/2017
Decision Date 10/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03093675
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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