Cleared Special

K153686 - SPIWay Endonasal Access Guide (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K153686 · Spiway, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.