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Evoked Response Electrical Stimulator

by Nucleus, Ltd.

510(k) K843226

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843226 Date21 May 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETN
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Evoked Response Electrical Stimulator is a medical device designed to stimulate nerve responses for diagnostic purposes. It is classified as a nerve stimulator and is used in ear, nose, and throat medical applications.

This device is supplied by Nucleus, Ltd. and is authorized under FDA 510K clearance. It is a Class II medical device with product code ETN and is regulated under regulation number 874.1820. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Evoked Response Electrical Stimulator used for?

    The Evoked Response Electrical Stimulator is designed to stimulate nerve responses for diagnostic purposes, specifically in ear, nose, and throat medical applications. It helps clinicians assess nerve function through controlled electrical stimulation.

  • Is the Evoked Response Electrical Stimulator single-use or reusable?

    The device data does not specify whether the Evoked Response Electrical Stimulator is single-use or reusable. This information would need to be obtained directly from the manufacturer, Nucleus, Ltd., or through the product's instructions for use.

  • What is the regulatory classification of the Evoked Response Electrical Stimulator?

    The Evoked Response Electrical Stimulator is a Class II medical device with product code ETN, regulated under number 874.1820. It received FDA 510K clearance in 1985, making it substantially equivalent to other legally marketed devices.

  • What information is available about sterility and storage conditions?

    The device data does not provide information regarding sterility status or specific storage conditions for the Evoked Response Electrical Stimulator. These details would be included in the product's instructions for use provided by the manufacturer.