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FDA 510(k)

SPIWay Endonasal Access Guide

K-Number: K213153 · 2021-10-27

ApplicantSpiway, LLC
Decision Date2021-10-27
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPIWay Endonasal Access Guide is the device name listed in this FDA 510(k) record. The listed applicant is Spiway, LLC. It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K213153. 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 2021-10-27. The listed applicant is Spiway, LLC. The 510(k) number is K213153.

When did SPIWay Endonasal Access Guide receive FDA 510(k) clearance?

SPIWay Endonasal Access Guide received FDA 510(k) clearance on 2021-10-27, under 510(k) number K213153.

Who is the listed applicant for SPIWay Endonasal Access Guide?

The FDA 510(k) record lists Spiway, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spiway, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180141SPIWay Endonasal Access GuideK153686SPIWay Endonasal Access Guide

Related Devices (Code: LYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLCK170913Composite Removable Sinus Stent SystemSts Medical

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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