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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteroscope And Accessories
510(k) Number K143556
Device Name Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
Applicant
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Applicant Contact MARY MOORE
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact MARY MOORE
Regulation Number876.1500
Classification Product Code
FDA  
Subsequent Product Code
FDF  
Date Received12/15/2014
Decision Date 08/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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