Cleared Special

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

K230320 · Medtronic Xomed, Inc. · Ear, Nose, Throat
Oct 2023
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K230320 is an FDA 510(k) clearance for the NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced 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 October 26, 2023, 262 days after receiving the submission on February 6, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K230320 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2023
Decision Date October 26, 2023
Days to Decision 262 days
Submission Type Special
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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