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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 K141077
Device Name DA VINCI FIREFLY IMAGING SYSTEM
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER RD
SUNNYVALE,  CA  94086
Applicant Contact MELISSA S GONZALEZ
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER RD
SUNNYVALE,  CA  94086
Correspondent Contact MELISSA S GONZALEZ
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Codes
GCJ   IZI  
Date Received04/25/2014
Decision Date 08/12/2014
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 Yes
Recalls CDRH Recalls
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