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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 K122532
Device Name DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
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  
Date Received08/20/2012
Decision Date 07/30/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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