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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 K130726
Device Name DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
sunnyvale,  CA  94086 -5206
Applicant Contact melissa s gonzalez
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
sunnyvale,  CA  94086 -5206
Correspondent Contact melissa s gonzalez
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received03/18/2013
Decision Date 06/07/2013
Decision se - with limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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