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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 K202834
Device Name da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Brandon Hansen
Correspondent
Domecus Consulting Services LLC
1171 Barroilhet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/25/2020
Decision Date 12/10/2020
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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