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ETN — Stimulator, Nerve Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K253536epineuron technologiesEvala Nerve Stimulator (EPNR002)February 27, 2026
K251672medtronic xomedNIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal TuFebruary 10, 2026
K242852inomed medizintechnikALM 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
K233001biosys biyomedikal muhendislik san. ve tic. a.sBioscope Neuromonitor DeviceDecember 13, 2024
K241917retropsoas technologiesEARP Nerve Cuff ElectrodeJuly 31, 2024
K232888suzhou haishen medical device associates coDisposable Laryngeal ElectrodesDecember 21, 2023
K230320medtronic xomedNIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG EndotracheOctober 26, 2023
K230853nvision biomedical technologiesEARP Nerve Cuff ElectrodeOctober 6, 2023
K231580medtronic xomedNIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)August 30, 2023
K223254inomed medizintechnikC2 XploreJanuary 27, 2023
K212164inomed medizintechnikMapping Suction ProbeNovember 11, 2022
K213246medtronic xomedNIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NMarch 21, 2022
K212355checkpoint surgicalCheckpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian IntraoperatAugust 26, 2021
K200886allotrope medicalStimSiteNovember 10, 2020
K152769ad-tech medical instrument corporationFREMAP ELECTRODEMay 6, 2016
K152505inomed medizintechnikC2 NerveMonitor SystemFebruary 1, 2016
K150005ndi medicalCheckpoint, Checkpoint Head & NeckFebruary 19, 2015
K133348spes medicaSTIM PROBENovember 21, 2014
K140400stryker corporationES2 NEUROMONITORING ACCESSORY INSTRUMENTSJuly 1, 2014
K122040invotec internationalINVOTEC LARYNGEAL ELECTRODEOctober 31, 2013