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Axon Systems Subdermal Needle Electrodes

by Axon Systems, Inc. 510(k)

Active United States

510(k) K050194

Overview

Axon Systems Subdermal Needle Electrodes are electrode devices designed for use with recording, monitoring, and stimulation equipment. They are intended to record biopotential signals such as electroencephalograph (EEG), electromyograph (EMG), and nerve potential signals, as well as for stimulation during intraoperative diagnosis of acute dysfunction.

The device is supplied as part of an FDA 510(k) cleared product (K050194) and is intended for use in clinical settings. Regulatory details include a device class of 2 and a regulation number of 882.1350. The device is not explicitly described as single-use, sterile, or MRI-safe in the provided data.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050194 Date26 Apr 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What are Axon Systems Subdermal Needle Electrodes used for?

    These electrodes are designed to record biopotential signals such as electroencephalograph (EEG), electromyograph (EMG), and nerve potential signals. They are also used for stimulation during intraoperative diagnosis of acute dysfunction.

  • How is the device supplied?

    The device is supplied as part of an FDA 510(k) cleared product (K050194) and is intended for use in clinical settings.

  • What are the regulatory details for this device?

    The device is classified as a Class 2 device with a regulation number of 882.1350. It was cleared through a 510(k) submission with a decision of Substantially Equivalent.

  • Is the device sterile or single-use?

    The provided data does not explicitly state whether the device is sterile or intended for single-use. Further clarification should be sought from the manufacturer or regulatory documentation.