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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 K182140
Device Name da Vinci Xi Surgical System, da Vinci X Surgical System
Applicant
Intuitive Surgical, Inc
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Brandon Hansen
Correspondent
Domecus Consulting Services LLC
1171 Barroihet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number876.1500
Classification Product Code
NAY  
Date Received08/07/2018
Decision Date 10/24/2018
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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