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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 K241284
Device Name da Vinci Surgical System (IS5000)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Jennifer Karafin
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Jennifer Karafin
Regulation Number876.1500
Classification Product Code
NAY  
Date Received05/07/2024
Decision Date 07/03/2024
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
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