ETN — Stimulator, Nerve Class II
FDA product code ETN covers "Stimulator, Nerve", a Class II medical device regulated under 21 CFR 874.1820. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ETN
- Device Class
- Class II
- Regulation Number
- 874.1820
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253536 | epineuron technologies | Evala Nerve Stimulator (EPNR002) | February 27, 2026 |
| K251672 | medtronic xomed | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tu | February 10, 2026 |
| K242852 | inomed medizintechnik | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM | June 13, 2025 |
| K233001 | biosys biyomedikal muhendislik san. ve tic. a.s | Bioscope Neuromonitor Device | December 13, 2024 |
| K241917 | retropsoas technologies | EARP Nerve Cuff Electrode | July 31, 2024 |
| K232888 | suzhou haishen medical device associates co | Disposable Laryngeal Electrodes | December 21, 2023 |
| K230320 | medtronic xomed | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache | October 26, 2023 |
| K230853 | nvision biomedical technologies | EARP Nerve Cuff Electrode | October 6, 2023 |
| K231580 | medtronic xomed | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | August 30, 2023 |
| K223254 | inomed medizintechnik | C2 Xplore | January 27, 2023 |
| K212164 | inomed medizintechnik | Mapping Suction Probe | November 11, 2022 |
| K213246 | medtronic xomed | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, N | March 21, 2022 |
| K212355 | checkpoint surgical | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperat | August 26, 2021 |
| K200886 | allotrope medical | StimSite | November 10, 2020 |
| K152769 | ad-tech medical instrument corporation | FREMAP ELECTRODE | May 6, 2016 |
| K152505 | inomed medizintechnik | C2 NerveMonitor System | February 1, 2016 |
| K150005 | ndi medical | Checkpoint, Checkpoint Head & Neck | February 19, 2015 |
| K133348 | spes medica | STIM PROBE | November 21, 2014 |
| K140400 | stryker corporation | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | July 1, 2014 |
| K122040 | invotec international | INVOTEC LARYNGEAL ELECTRODE | October 31, 2013 |