Cleared Special

K153686 - SPIWay Endonasal Access Guide

K153686 is an FDA 510(k) clearance for SPIWay Endonasal Access Guide, manufactured by Spiway, LLC. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Special 510(k) pathway after a 36-day FDA review.

K153686 · Spiway, LLC · Ear, Nose, Throat device
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Jan 2016
Decision
36d
Days
Class 1
Risk

K153686 is an FDA 510(k) clearance for the SPIWay Endonasal Access Guide. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Spiway, LLC (San Clemente, US). The FDA issued a Cleared decision on January 28, 2016 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spiway, LLC devices

FDA 510(k) Submission Details - K153686

510(k) Number K153686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date January 28, 2016
Days to Decision 36 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 89d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

LYA Device Classification - Class 1, General Controls

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYA Splint, Intranasal Septal

All 20
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K153686.
Novapak Nasal Sinus Packing and Stent
K202623 · Medtronic Xomed · Dec 2020
ChitoZolve
K181696 · Gyrus Acmi, Inc. · Nov 2018
SPIWay Endonasal Access Guide
K180141 · Spiway, LLC · Feb 2018
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc. · Oct 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004