ETN · Class II · 21 CFR 874.1820

FDA Product Code ETN: Stimulator, Nerve

FDA product code ETN covers nerve stimulators used in otolaryngology and skull base surgery.

These devices deliver controlled electrical stimuli to identify and map cranial nerves intraoperatively — particularly the facial nerve during parotid, acoustic neuroma, and mastoid surgery — reducing the risk of permanent nerve injury. Real-time electromyographic feedback alerts the surgeon when the probe is near nerve tissue.

ETN devices are Class II medical devices, regulated under 21 CFR 874.1820 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include Medtronic Xomed, Inc. and Nvision Biomedical Technologies, Inc..

5
Total
5
Cleared
195d
Avg days
2022
Since

List of Stimulator, Nerve devices cleared through 510(k)

5 devices
1–5 of 5
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320
Medtronic Xomed, Inc.
Ear, Nose, Throat · 262d
Cleared Oct 06, 2023
EARP Nerve Cuff Electrode
K230853
Nvision Biomedical Technologies, Inc.
Neurology · 192d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580
Medtronic Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K213246
Medtronic Xomed, Inc.
Ear, Nose, Throat · 172d

How to use this database

This page lists all FDA 510(k) submissions for Stimulator, Nerve devices (product code ETN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →