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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K163209
Device Name Fiagon Navigation System
Applicant
Fiagon GmbH
Neuendorfstrasse 23b
Hennigsdorf,  DE 16761
Applicant Contact Dirk Mucha
Correspondent
Hogan Lovells US LLP
3 Embarcadero Center Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/15/2016
Decision Date 09/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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