Cleared Traditional

K140992 - ARTHROCARE NASASTENT CMC NASAL DRESSING (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K140992 · ArthroCare Corporation · Ear, Nose, Throat device
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Jun 2014
Decision
60d
Days
Class 1
Risk

K140992 is an FDA 510(k) clearance for the ARTHROCARE NASASTENT CMC NASAL DRESSING. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by ArthroCare Corporation (Austin, US). The FDA issued a Cleared decision on June 16, 2014 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ArthroCare Corporation devices

Submission Details

510(k) Number K140992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date June 16, 2014
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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.