Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K162176
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
PGW  
Date Received08/03/2016
Decision Date 12/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-