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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K172916
Device Name FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
Applicant
Fujifilm Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun Kanagawa,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received09/25/2017
Decision Date 03/01/2018
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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