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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 K192803
Device Name da Vinci Xi Surgical System, da Vinci X Surgical System
Applicant
Intuitive Surgical
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Crystal Ong
Correspondent
Intuitive Surgical
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Crystal Ong
Regulation Number876.1500
Classification Product Code
NAY  
Date Received09/30/2019
Decision Date 04/29/2020
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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