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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 K150284
Device Name IS4000 da Vinci EndoWrist Instruments
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Applicant Contact Sarah Rizk
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Correspondent Contact Sarah Rizk
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received02/05/2015
Decision Date 05/15/2015
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
Recalls CDRH Recalls
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