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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 K101743
Device Name 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Applicant Contact KAREN UYESUGI
Correspondent
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Correspondent Contact KAREN UYESUGI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received06/22/2010
Decision Date 02/04/2011
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
Recalls CDRH Recalls
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