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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 K180163
Device Name TransEnterix Senhance Surgical 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 Received01/19/2018
Decision Date 05/25/2018
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
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