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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 K200049
Device Name Senhance Surgical System
Applicant
Transenterix, Inc.
635 Davis Dr., Suite 300
Morrisville,  NC  27650
Applicant Contact Kaitlyn Alexander
Correspondent
Transenterix, Inc.
635 Davis Dr., Suite 300
Morrisville,  NC  27650
Correspondent Contact Kaitlyn Alexander
Regulation Number876.1500
Classification Product Code
NAY  
Date Received01/09/2020
Decision Date 03/09/2020
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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