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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K261540
Device Name Cube 4D Navigation System, VirtuEye Pro
Applicant
Fiagon GmbH
Neuendorfstr. 23b
Hennigsdorf,  DE 16761
Applicant Contact Magdalena Giba
Correspondent
Fiagon GmbH
Neuendorfstr. 23b
Hennigsdorf,  DE 16761
Correspondent Contact Magdalena Giba
Regulation Number882.4560
Classification Product Code
PGW  
Date Received05/08/2026
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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