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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 K123463
Device Name INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BLDG. 101
SUNNYVALE,  CA  94086 -5206
Applicant Contact CRYSTAL ONG
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BLDG. 101
SUNNYVALE,  CA  94086 -5206
Correspondent Contact CRYSTAL ONG
Regulation Number876.1500
Classification Product Code
NAY  
Date Received11/09/2012
Decision Date 12/03/2012
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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