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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 K183086
Device Name da Vinci X and Xi Surgical System
Applicant
Intuitive Surgical, Inc
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Brandon Hansen
Correspondent
Domecus Consulting Services LLC
Correspondent Contact Mark Johnson
Regulation Number876.1500
Classification Product Code
NAY  
Date Received11/06/2018
Decision Date 03/31/2020
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
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