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FDA 510(k)

GuideWire

K-Number: K160369 · 2016-03-10

ApplicantFiagon GmbH
Decision Date2016-03-10
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GuideWire is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2016-03-10 under approval number K160369. 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 GuideWire?

GuideWire is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Fiagon GmbH. The 510(k) number is K160369.

When was GuideWire approved by the FDA?

GuideWire received FDA 510(k) clearance on 2016-03-10, under approval number K160369.

What company makes GuideWire?

GuideWire is manufactured by Fiagon GmbH.

What is the FDA product code for GuideWire?

The FDA product code for GuideWire is PGW.

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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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