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FDA 510(k)

Fiagon Navigation – PointerTube Straight and PointerTube Keat

K-Number: K163416 · 2017-02-16

ApplicantFiagon GmbH
Decision Date2017-02-16
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fiagon Navigation – PointerTube Straight and PointerTube Keat is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2017-02-16 under approval number K163416. 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 – PointerTube Straight and PointerTube Keat?

Fiagon Navigation – PointerTube Straight and PointerTube Keat is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Fiagon GmbH. The 510(k) number is K163416.

When was Fiagon Navigation – PointerTube Straight and PointerTube Keat approved by the FDA?

Fiagon Navigation – PointerTube Straight and PointerTube Keat received FDA 510(k) clearance on 2017-02-16, under approval number K163416.

What company makes Fiagon Navigation – PointerTube Straight and PointerTube Keat?

Fiagon Navigation – PointerTube Straight and PointerTube Keat is manufactured by Fiagon GmbH.

What is the FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

The FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat is PGW.

Other Devices by Fiagon GmbH

K162176Fiagon Navigation System K161940Guidewire 0.6 Single Use K151156Fiagon Navigation System K160479PointerShell Universal, PointerShell LS K160369GuideWire K163209Fiagon Navigation System

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH 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.

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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