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LOW PROFILE EEG NEEDLE ELECTRODE - 112-812-48TP

by Class A Enterprises, Inc.

510(k) K023472

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 NumberK023472 Date18 Mar 2003ClearedStatusActive

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  • Withdrawn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
GXZ
Models / Variants
112-812-48TP
Device Class
Class II
Regulation
21 CFR Part 882.1350
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Low Profile EEG Needle Electrode is a subdermal needle electrode designed for electroencephalography (EEG) to record electrical brain activity. These electrodes are inserted into the scalp to detect minute waveforms, serving as an accessory to EEG machines for neurological assessments. The device facilitates precise monitoring of brain function through non-invasive scalp insertion, aiding in diagnostic evaluations for neurological conditions.

Supplied as single-use, sterile electrodes, these models (112-812-18TP through 112-812-96TP) are intended for use in clinical settings under medical supervision. The electrodes are classified as Class II devices under FDA regulations (882.1350) and have received a 510(k) clearance via a traditional pathway. Each model varies by length, ensuring compatibility with different patient anatomies, and must be stored in a clean, dry environment prior to use.

Questions

AI-generated answers, 1 Oct 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 Low Profile EEG Needle Electrode used for?

    The Low Profile EEG Needle Electrode is designed for electroencephalography (EEG) to record electrical brain activity. These electrodes are inserted under the scalp to detect subtle waveforms, serving as an accessory to EEG machines. They aid in diagnosing neurological conditions by enabling precise, non-invasive monitoring of brain function under medical supervision.

  • Are these electrodes single-use or reusable?

    These electrodes are supplied as single-use only. Each package is sterile and intended for one-time clinical use to ensure patient safety and maintain electrode integrity. Reuse is not recommended or approved.

  • What lengths are available for the Low Profile EEG Needle Electrode?

    The device is available in six distinct lengths: 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, and 112-812-96TP, along with the base model 112-812. These variations accommodate different patient anatomies and clinical needs.

  • How should these electrodes be stored before use?

    Prior to use, the electrodes must be stored in a clean, dry environment to preserve sterility and functionality. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions can compromise the device’s integrity.

  • Are these electrodes sterile when packaged?

    Yes, the Low Profile EEG Needle Electrode is supplied sterile in its packaging. Sterility is maintained until the package is opened, ensuring safe single-use in clinical settings.