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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 K231224
Device Name da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Suunyvale,  CA  94086
Applicant Contact Michael Prutton
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Suunyvale,  CA  94086
Correspondent Contact Michael Prutton
Regulation Number876.1500
Classification Product Code
NAY  
Date Received04/28/2023
Decision Date 05/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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