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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 K120215
Models 425055, 425058, 428053, 428059
Device Name SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
Original Applicant
INTUITIVE SURGICAL, INC.
1450 kifer rd
--
sunnyvale,  CA  94086
Original Contact kim t servance
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received01/24/2012
Decision Date 04/30/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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