JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

Endoscope Channel Accessory

FUJIFILM Medwork GmbH

The following data is part of a premarket notification filed by Fujifilm Medwork Gmbh with the FDA for Jazz Suction Valve, Jazz Air/water Valve, Jazz Forceps Valve.

Pre-market Notification Details

Device IDK210625
510k NumberK210625
Device Name:JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
ClassificationEndoscope Channel Accessory
Applicant FUJIFILM Medwork GmbH Medworkring 1 Hochstadt,  DE 91315
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-02
Decision Date2021-09-10

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