Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820) → ETN — Stimulator, Nerve # ETN · Stimulator, Nerve _Ear, Nose, Throat · 21 CFR 874.1820 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN ## Overview - **Product Code:** ETN - **Device Name:** Stimulator, Nerve - **Regulation:** [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820) - **Device Class:** 2 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K253536.md) | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | Feb 27, 2026 | SESE | | [K251672](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K251672.md) | 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](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K242852.md) | 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](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K233001.md) | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Dec 13, 2024 | SESE | | [K241917](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K241917.md) | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | Jul 31, 2024 | SESE | | [K232888](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K232888.md) | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 21, 2023 | SESE | | [K230320](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K230320.md) | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | Oct 26, 2023 | SESE | | [K230853](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K230853.md) | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | Oct 6, 2023 | SESE | | [K231580](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K231580.md) | NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | Aug 30, 2023 | SESE | | [K223254](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K223254.md) | C2 Xplore | Inomed Medizintechnik GmbH | Jan 27, 2023 | SESE | | [K212164](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K212164.md) | Mapping Suction Probe | Inomed Medizintechnik GmbH | Nov 11, 2022 | SESE | | [K213246](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K213246.md) | 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](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K212355.md) | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | Aug 26, 2021 | SESE | | [K200886](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K200886.md) | StimSite | Allotrope Medical, Inc. | Nov 10, 2020 | SESE | | [K152769](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K152769.md) | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | May 6, 2016 | SESE | | [K152505](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K152505.md) | C2 NerveMonitor System | Inomed Medizintechnik GmbH | Feb 1, 2016 | SESE | | [K150005](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K150005.md) | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | Feb 19, 2015 | SESE | | [K133348](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K133348.md) | STIM PROBE | Spes Medica Srl | Nov 21, 2014 | SESE | | [K140400](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K140400.md) | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | Jul 1, 2014 | SESE | | [K122040](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K122040.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com