Cleared Special

K213153 - SPIWay Endonasal Access Guide (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K213153 · Spiway, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Oct 2021
Decision
29d
Days
Class 1
Risk

K213153 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 (Carlsbad, US). The FDA issued a Cleared decision on October 27, 2021 after a review of 29 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 K213153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date October 27, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 89d · This submission: 29d
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.