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FDA 510(k)

Fiagon Navigation System

K-Number: K163209 · 2017-09-14

ApplicantFiagon GmbH
Decision Date2017-09-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fiagon Navigation System is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2017-09-14 under approval number K163209. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fiagon Navigation System?

Fiagon Navigation System is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Fiagon GmbH. The 510(k) number is K163209.

When was Fiagon Navigation System approved by the FDA?

Fiagon Navigation System received FDA 510(k) clearance on 2017-09-14, under approval number K163209.

What company makes Fiagon Navigation System?

Fiagon Navigation System is manufactured by Fiagon GmbH.

What is the FDA product code for Fiagon Navigation System?

The FDA product code for Fiagon Navigation System is HAW.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Fiagon GmbH

K162176Fiagon Navigation System K161940Guidewire 0.6 Single Use K151156Fiagon Navigation System K160479PointerShell Universal, PointerShell LS K160369GuideWire K163416Fiagon Navigation – PointerTube Straight and PointerTube Keat

View all 12 devices →

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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