Cleared Traditional

NIM Essence? EMG Endotracheal Tube (NIMEID060); NIM Essence? EMG Endotracheal Tube (NIMEID065); NIM Essence? EMG Endotracheal Tube (NIMEID070); NIM Essence? EMG Endotracheal Tube (NIMEID075); NIM Essence? EMG Endotracheal Tube (NIMEID080)

K251672 · Medtronic Xomed, Inc. · Ear, Nose, Throat
Feb 2026
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K251672 is an FDA 510(k) clearance for the NIM Essence? EMG Endotracheal Tube (NIMEID060); NIM Essence? EMG Endotracheal Tube (NIMEID065); NIM Essence? EMG Endotracheal Tube (NIMEID070); NIM Essence? EMG Endotracheal Tube (NIMEID075); NIM Essence? EMG Endotracheal Tube (NIMEID080), a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 10, 2026, 256 days after receiving the submission on May 30, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K251672 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date February 10, 2026
Days to Decision 256 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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