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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 K240852
Device Name da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
Applicant
Intuitive Surgical, Inc.
1020 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Mike Yramategui
Correspondent
Intuitive Surgical, Inc.
1020 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Mike Yramategui
Regulation Number876.1500
Classification Product Code
NAY  
Date Received03/28/2024
Decision Date 06/11/2025
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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