ETN
- Product code
- ETN
- Device name
- Stimulator, Nerve
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.1820
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 97 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253536 | 2026-02-27 | Epineuron Technologies, Inc. | Evala Nerve Stimulator (EPNR002) | |
| K251672 | 2026-02-10 | Medtronic Xomed, Inc. | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM … | |
| K242852 | 2025-06-13 | Inomed Medizintechnik GmbH | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. … | |
| K233001 | 2024-12-13 | Biosys Biyomedikal Muhendislik San. VE… | Bioscope Neuromonitor Device | |
| K241917 | 2024-07-31 | Retropsoas Technologies, LLC | EARP Nerve Cuff Electrode | |
| K232888 | 2023-12-21 | Suzhou Haishen Medical Device Associat… | Disposable Laryngeal Electrodes | |
| K230320 | 2023-10-26 | Medtronic Xomed, Inc. | NIM Standard Reinforced EMG Endotracheal Tube; CONTA… | |
| K230853 | 2023-10-06 | Nvision Biomedical Technologies, Inc. | EARP Nerve Cuff Electrode |
Official FDA classification page: ETN
Classification and pathway per current FDA publications. Data from openFDA (CC0).