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Cutaneous (Bar) Electrode

by Neuro Supplies, Inc.

510(k) K991769

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 NumberK991769 Date18 Aug 1999ClearedStatusActive

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  • Withdrawn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
GXY
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Cutaneous (Bar) Electrode is a non-invasive interface for electrophysiological monitoring that captures electrical signals from the skin surface or delivers electrical stimulation to underlying nerves or muscles. It is used by clinicians during EMG, NCS, and EP procedures to obtain raw electrical data for diagnostic interpretation.

The device is supplied as a reusable electrode and is authorized under FDA 510(k) clearance K991769. It is intended for use in clinical electrophysiological testing environments and is not indicated for any specific therapeutic application beyond signal acquisition or stimulation as described.

Other devices from Neuro Supplies, Inc.

Questions

AI-generated answers, 6 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 Cutaneous (Bar) Electrode used for?

    It is a non-invasive interface used during EMG, NCS, and EP procedures to capture electrical signals from the skin surface or deliver electrical stimulation to underlying nerves or muscles for diagnostic interpretation.

  • Is the Cutaneous (Bar) Electrode reusable or single-use?

    The device is supplied as a reusable electrode, meaning it can be cleaned and used multiple times following appropriate clinical cleaning protocols.

  • What regulatory authorization does the Cutaneous (Bar) Electrode have?

    It is authorized under FDA 510(k) clearance K991769, determined to be substantially equivalent to a predicate device.