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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 K131962
Device Name DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Applicant Contact MIKE YRAMATEGUI
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Correspondent Contact MIKE YRAMATEGUI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received06/27/2013
Decision Date 04/17/2014
Decision SE - With Limitations (SESU)
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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