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E-Shield Multi-paried Subdermal Needle Electrodes

by Neuroinvent, Inc.

510(k) K142470

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 · Special NumberK142470 Date5 Nov 2014ClearedStatusActive

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  • Withdrawn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
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 E-Shield Multi-Paired Subdermal Needle Electrodes are subdermal needle electrodes designed for recording biopotential signals. These monopolar, stainless steel electrodes are intended for subcutaneous placement to facilitate precise electrical signal acquisition during neurological monitoring or recording procedures.

These electrodes are supplied as sterile, single-use devices featuring five paired needle sets with integrated safety shields to protect against sharps injuries. Each set includes grouped lead wires for organized routing to recording sites. The device is classified under product code GXZ as a Class II medical device under FDA Special Controls (regulation number 882.1350) and received FDA 510(k) clearance (K142470) in 2014.

Other devices from Neuroinvent, Inc.

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 E-Shield Multi-Paired Subdermal Needle Electrodes used for?

    The E-Shield Multi-Paired Subdermal Needle Electrodes are designed for recording biopotential signals during neurological monitoring or recording procedures. They are intended for subcutaneous placement to facilitate precise electrical signal acquisition, making them suitable for applications requiring detailed neural activity capture, such as intraoperative monitoring or research studies.

  • Are these electrodes single-use or reusable?

    These electrodes are strictly single-use devices. This design ensures patient safety by eliminating the risk of cross-contamination and maintains signal integrity, as reuse could compromise sterility and performance. Each package is intended for one-time use only.

  • How are the electrodes supplied, and what safety features do they include?

    The electrodes are supplied as sterile, pre-packaged devices. Each set includes five paired needle sets with integrated safety shields, which protect against sharps injuries during handling and use. The lead wires are grouped for organized routing to recording sites, simplifying setup and reducing clutter.

  • What materials are used in the construction of these electrodes?

    The E-Shield Multi-Paired Subdermal Needle Electrodes are made from stainless steel, a durable and biocompatible material suitable for subcutaneous placement. The safety shields are designed to complement the needle construction while ensuring user safety.

  • How should these electrodes be stored?

    These electrodes should be stored in their original, sterile packaging until use. The packaging should be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures sterility and maintains the integrity of the device for its intended single-use application.