FROG Forceps Valve (VAL1-F1-100)

Endoscope Channel Accessory

FUJIFILM Medwork GmbH

The following data is part of a premarket notification filed by Fujifilm Medwork Gmbh with the FDA for Frog Forceps Valve (val1-f1-100).

Pre-market Notification Details

Device IDK221264
510k NumberK221264
Device Name:FROG Forceps Valve (VAL1-F1-100)
ClassificationEndoscope Channel Accessory
Applicant FUJIFILM Medwork GmbH Medworkring 1 Hochstadt,  DE 91315
ContactRandy Vader
CorrespondentDhara Buch
FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-06-01

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