FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Ear, Nose, And Throat Stereotaxic Instrument

Fiagon GmbH

The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Flexpointer 1.5 Single Use, Flextube 3 Single Use.

Pre-market Notification Details

Device IDK200041
510k NumberK200041
Device Name:FlexPointer 1.5 Single Use, FlexTube 3 Single Use
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf,  DE 16761
ContactDirk Mucha
CorrespondentDirk Mucha
Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf,  DE 16761
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelEar Nose & Throat
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-08
Decision Date2020-03-10

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