Cleared Traditional

NONDISPOSABLE STIMULATING INSTRUMENTS

K121931 · Neurovision Medical Products, Inc. · Ear, Nose, Throat
Oct 2012
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K121931 is an FDA 510(k) clearance for the NONDISPOSABLE STIMULATING INSTRUMENTS, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on October 19, 2012, 109 days after receiving the submission on July 2, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K121931 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2012
Decision Date October 19, 2012
Days to Decision 109 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

Similar Devices — ETN Stimulator, Nerve

All 96
Evala Nerve Stimulator (EPNR002)
K253536 · Epineuron Technologies, Inc. · Feb 2026
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)
K251672 · Medtronic Xomed, Inc. · Feb 2026
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)
K242852 · Inomed Medizintechnik GmbH · Jun 2025
Bioscope Neuromonitor Device
K233001 · Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · Dec 2024
EARP Nerve Cuff Electrode
K241917 · Retropsoas Technologies, LLC · Jul 2024
Disposable Laryngeal Electrodes
K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023