FUJIFILM Duodenoscope Model

Duodenoscope And Accessories, Flexible/rigid

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Duodenoscope Model.

Pre-market Notification Details

Device IDK181745
510k NumberK181745
Device Name:FUJIFILM Duodenoscope Model
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 40 Boroline Road Allendale,  NJ  07401
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-02
Decision Date2019-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410359282 K181745 000
04547410330663 K181745 000

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