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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 K101581
Device Name INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Applicant Contact BRANDON HANSEN
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Correspondent Contact BRANDON HANSEN
Regulation Number876.1500
Classification Product Code
NAY  
Date Received06/07/2010
Decision Date 04/08/2011
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
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