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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 K112208
Device Name INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER RD
SUNNYVALE,  CA  94086
Applicant Contact BRANDON HANSEN
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER RD
SUNNYVALE,  CA  94086
Correspondent Contact BRANDON HANSEN
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received08/01/2011
Decision Date 12/08/2011
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
Recalls CDRH Recalls
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