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FDA 510(k)

Fiagon Navigation System

K-Number: K162176 · 2016-12-01

ApplicantFiagon GmbH
Decision Date2016-12-01
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fiagon Navigation System is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2016-12-01 under approval number K162176. The device is classified under product code PGW. 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 2016-12-01. It is manufactured by Fiagon GmbH. The 510(k) number is K162176.

When was Fiagon Navigation System approved by the FDA?

Fiagon Navigation System received FDA 510(k) clearance on 2016-12-01, under approval number K162176.

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 PGW.

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

K161940Guidewire 0.6 Single Use K151156Fiagon Navigation System K160479PointerShell Universal, PointerShell LS K160369GuideWire K163209Fiagon Navigation System K163416Fiagon Navigation – PointerTube Straight and PointerTube Keat

View all 12 devices →

Related Devices (Code: PGW)

K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc. K160479PointerShell Universal, PointerShell LSFiagon 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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