Cleared Traditional

K132297 - EM SINUS DILATION SYSTEM (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K132297 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Nov 2013
Decision
104d
Days
Class 1
Risk

K132297 is an FDA 510(k) clearance for the EM SINUS DILATION SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 5, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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.

View all Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K132297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2013
Decision Date November 05, 2013
Days to Decision 104 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
15d slower than avg
Panel avg: 89d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.