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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 K142683
Device Name 12 mm Endoscopes and Accessories
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086 -5206
Applicant Contact Crystal Ong
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086 -5206
Correspondent Contact Crystal Ong
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
KCT  
Date Received09/19/2014
Decision Date 12/10/2014
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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