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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 K182421
Device Name Senhance Ultrasonic System
Applicant
TransEnterix, Inc.
635 Davis Drive Suite 300
Morrisville,  NC  27650
Applicant Contact Stephanie M. Fitts
Correspondent
TransEnterix, Inc.
635 Davis Drive Suite 300
Morrisville,  NC  27650
Correspondent Contact Stephanie M. Fitts
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/05/2018
Decision Date 01/11/2019
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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