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510(k) K163209

Fiagon Navigation System by Fiagon GmbH — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2017
Date Received
November 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use (March 10, 2020)
  • K163416 — Fiagon Navigation – PointerTube Straight and PointerTube Keat (February 16, 2017)
  • K162176 — Fiagon Navigation System (December 1, 2016)
  • K161940 — Guidewire 0.6 Single Use (September 18, 2016)
  • K151156 — Fiagon Navigation System (April 1, 2016)
  • K160479 — PointerShell Universal, PointerShell LS (March 23, 2016)

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