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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 K240723
Device Name da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Applicant
Intuitive Surgical
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact Emily Hovick
Correspondent
Intuitive Surgical
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact Emily Hovick
Regulation Number876.1500
Classification Product Code
NAY  
Date Received03/18/2024
Decision Date 05/24/2024
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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