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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 K253556
Device Name da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  90486
Applicant Contact Manjunath Ramappa Bisalehalli
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  90486
Correspondent Contact Manjunath Ramappa Bisalehalli
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GEI  
Date Received11/14/2025
Decision Date 01/16/2026
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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