ETN · Stimulator, Nerve
Ear, Nose, Throat · 21 CFR 874.1820 · Class 2
Overview
| Product Code | ETN |
|---|---|
| Device Name | Stimulator, Nerve |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 97)
Showing 20 most recent of 97 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | Feb 27, 2026 | SESE |
| K251672 | 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) | Medtronic Xomed, Inc. | Feb 10, 2026 | SESE |
| K242852 | 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) | Inomed Medizintechnik GmbH | Jun 13, 2025 | SESE |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Dec 13, 2024 | SESE |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | Jul 31, 2024 | SESE |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 21, 2023 | SESE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | Oct 26, 2023 | SESE |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | Oct 6, 2023 | SESE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | Aug 30, 2023 | SESE |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | Jan 27, 2023 | SESE |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | Nov 11, 2022 | SESE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | Mar 21, 2022 | SESE |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | Aug 26, 2021 | SESE |
| K200886 | StimSite | Allotrope Medical, Inc. | Nov 10, 2020 | SESE |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | May 6, 2016 | SESE |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | Feb 1, 2016 | SESE |
| K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | Feb 19, 2015 | SESE |
| K133348 | STIM PROBE | Spes Medica Srl | Nov 21, 2014 | SESE |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | Jul 1, 2014 | SESE |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | Oct 31, 2013 | SESE |
Top Applicants
- Medtronic Xomed, Inc. — 9 clearances
- The Magstim Company , Ltd. — 9 clearances
- Nuvasive, Inc. — 6 clearances
- Inomed Medizintechnik GmbH — 5 clearances
- Neurovision Medical Products, Inc. — 5 clearances
