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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K171096
Device Name Fujifilm Diathermic Slitter (FlushKnife)
Applicant
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Applicant Contact Jeffrey Wan
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact Jeffrey Wan
Regulation Number876.4300
Classification Product Code
KGE  
Date Received04/13/2017
Decision Date 05/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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