FDA 510(k)

SPIWay Endonasal Access Guide

K-Number: K180141 · 2018-02-16

Decision Date2018-02-16

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

SPIWay Endonasal Access Guide is a medical device manufactured by Spiway, LLC. It received FDA 510(k) clearance on 2018-02-16 under approval number K180141. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIWay Endonasal Access Guide?

SPIWay Endonasal Access Guide is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Spiway, LLC. The 510(k) number is K180141.

When was SPIWay Endonasal Access Guide approved by the FDA?

SPIWay Endonasal Access Guide received FDA 510(k) clearance on 2018-02-16, under approval number K180141.

What company makes SPIWay Endonasal Access Guide?

SPIWay Endonasal Access Guide is manufactured by Spiway, LLC.

What is the FDA product code for SPIWay Endonasal Access Guide?

The FDA product code for SPIWay Endonasal Access Guide is LYA.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED

Other Devices by Spiway, LLC

K153686SPIWay Endonasal Access Guide K213153SPIWay Endonasal Access Guide

Related Devices (Code: LYA)

K153686SPIWay Endonasal Access GuideSpiway, LLC K170913Composite Removable Sinus Stent SystemSts Medical K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. K181696ChitoZolveGyrus Acmi, Inc. K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed K213153SPIWay Endonasal Access GuideSpiway, LLC

Official Source

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