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., Inomed Medizintechnik GmbH and Checkpoint Surgical.

97
Total
97
Cleared
143d
Avg days
1978
Since
Stable submission activity - 5 submissions in the last 2 years
Review times increasing: avg 221d recently vs 139d historically

FDA 510(k) Cleared Stimulator, Nerve Devices (Product Code ETN)

97 devices
1–24 of 97
Cleared Feb 27, 2026
Evala Nerve Stimulator (EPNR002)
K253536
Epineuron Technologies, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Jun 13, 2025
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
K242852
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 266d
Cleared Dec 13, 2024
Bioscope Neuromonitor Device
K233001
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
Ear, Nose, Throat · 448d
Cleared Jul 31, 2024
EARP Nerve Cuff Electrode
K241917
Retropsoas Technologies, LLC
Neurology · 30d
Cleared Dec 21, 2023
Disposable Laryngeal Electrodes
K232888
Suzhou Haishen Medical Device Associates Co., Ltd.
Ear, Nose, Throat · 94d
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 Jan 27, 2023
C2 Xplore
K223254
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 98d
Cleared Nov 11, 2022
Mapping Suction Probe
K212164
Inomed Medizintechnik GmbH
Neurology · 487d
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
Cleared Aug 26, 2021
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K212355
Checkpoint Surgical
Ear, Nose, Throat · 28d
Cleared Nov 10, 2020
StimSite
K200886
Allotrope Medical, Inc.
Obstetrics & Gynecology · 222d
Cleared Dec 07, 1978
NERVE LOCATER/STIMULATOR
K781569
Intermedics, Inc.
Ear, Nose, Throat · 84d

About Product Code ETN - Regulatory Context

510(k) Submission Activity

97 total 510(k) submissions under product code ETN since 1978, with 97 receiving FDA clearance (average review time: 143 days).

Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.

FDA 510(k) Review Time - ETN Product Code

Recent submissions under ETN have taken an average of 221 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.

ETN devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →