Cleared Traditional

K132721 - SPIWAY ENDONASAL ACCESS GUIDE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K132721 · Spiway, LLC · Ear, Nose, Throat device
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Jan 2014
Decision
152d
Days
Class 1
Risk

K132721 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 (Laguna Beach, US). The FDA issued a Cleared decision on January 29, 2014 after a review of 152 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K132721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date January 29, 2014
Days to Decision 152 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 89d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

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.