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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 K141075
Device Name SINGLE-SITE WRISTED NEEDLE DRIVER
Applicant
INTUITIVE SURGICAL
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Applicant Contact EINAV YEMINI
Correspondent
INTUITIVE SURGICAL
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Correspondent Contact EINAV YEMINI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received04/25/2014
Decision Date 09/26/2014
Decision SE - With Limitations (SESU)
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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