Cleared Traditional

EM SINUS DILATION SYSTEM

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

About This 510(k) Submission

K132297 is an FDA 510(k) clearance for the EM SINUS DILATION SYSTEM, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 5, 2013, 104 days after receiving the submission on July 24, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K132297 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420

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