THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL

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 The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell.

Pre-market Notification Details

Device IDK141456
510k NumberK141456
Device Name:THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-02
Decision Date2014-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EFIAE0129111 K141456 000
04260759930362 K141456 000
04260759930379 K141456 000
04260759930386 K141456 000
EFIAE0120031 K141456 000
EFIAE0121041 K141456 000
EFIAE0121061 K141456 000
EFIAE0129001 K141456 000
EFIAE0129011 K141456 000
EFIAE0129021 K141456 000
EFIAE0121011 K141456 000
EFIAE0121021 K141456 000
EFIAE0121031 K141456 000
EFIAE0129101 K141456 000
04260759930119 K141456 000

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