FDA product code ETN: Stimulator, Nerve
ETN is the FDA product code for stimulator, nerve. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 97 510(k) submissions under ETN, 12 in the last five years, from 51 different applicants. The average 510(k) review took 143 days (median 115); 229 days on average over the last three years. FDA has posted 31 recalls for ETN devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve |
| Device class | Class II |
| Regulation | 21 CFR 874.1820 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for ETN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 222 |
| 2021 | 1 | 28 |
| 2022 | 2 | 330 |
| 2023 | 5 | 147 |
| 2024 | 2 | 239 |
| 2025 | 1 | 266 |
| 2026 | 2 | 181 |
Top ETN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Xomed, Inc. | 9 | 2026-02-10 |
| The Magstim Company , Ltd. | 9 | 2009-07-29 |
| Nuvasive, Inc. | 6 | 2012-04-13 |
| Inomed Medizintechnik GmbH | 5 | 2025-06-13 |
| Neurovision Medical Products, Inc. | 5 | 2012-10-19 |
46 more applicants have ETN clearances. See the full list in Caduvo.
Most recent ETN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253536 | Epineuron Technologies, Inc. | Evala Nerve Stimulator (EPNR002) | 2026-02-27 | 106 |
| K251672 | Medtronic Xomed, Inc. | 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) | 2026-02-10 | 256 |
| K242852 | Inomed Medizintechnik GmbH | 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) | 2025-06-13 | 266 |
| K233001 | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Bioscope Neuromonitor Device | 2024-12-13 | 448 |
| K241917 | Retropsoas Technologies, LLC | EARP Nerve Cuff Electrode | 2024-07-31 | 30 |
Recalls for ETN devices
31 product recalls in 17 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-05-19.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 10 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code ETN?
ETN is the FDA product code for stimulator, nerve. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Ear, Nose and Throat panel.
What device class is ETN?
Class II, regulation 21 CFR 874.1820. Typical premarket route: 510(k).
How long does a 510(k) take for product code ETN?
Across 97 cleared submissions the average was 143 days from receipt to decision (median 115).
Which companies have the most ETN clearances?
Medtronic Xomed, Inc. (9); The Magstim Company , Ltd. (9); Nuvasive, Inc. (6); Inomed Medizintechnik GmbH (5); Neurovision Medical Products, Inc. (5).
Have ETN devices been recalled?
Yes: 31 product recalls across 17 recall events; the most recent began 2025-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code ETN
- Run a recall and safety report across every ETN manufacturer
- Watch product code ETN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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