Cleared Traditional

NEXT GEN EMG ENDOTRACHEAL TUBE

K112686 · Medtronic Xomed, Inc. · Ear, Nose, Throat
Jun 2012
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K112686 is an FDA 510(k) clearance for the NEXT GEN EMG ENDOTRACHEAL TUBE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 27, 2012, 286 days after receiving the submission on September 15, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K112686 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2011
Decision Date June 27, 2012
Days to Decision 286 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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