Spinal Electrode

by Ad-Tech Medical Instrument Corp.

510(k) K973454

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

510(k) K973454↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK973454	Date10 Jun 1998Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Ad-Tech's Spinal Electrode

510(k) Number: K973454
FDA product code: GZL
FDA applicant: Ad-Tech Medical Instrument Corp

Device class: Class II
Regulation: 21 CFR Part 882.1330
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Spinal Electrode is a depth electrode designed for neuromonitoring applications, specifically for recording motor evoked potentials (MEPs) during surgical procedures. It facilitates real-time assessment of spinal cord function, aiding in the prevention of intraoperative neurological injury.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under product code GZL. It is classified as a Class II medical device (regulation number 882.1330) and is used in neurosurgical settings. The electrode is intended for use in MRI-safe environments, as indicated by its regulatory classification and intended application in neuromonitoring procedures.

From the manufacturer

Ad-Tech Medical Instrument Corporation The World's Leader As the world leader, Ad-Tech's electrode devices are used in surgical cases for long-term EEG monitoring*, brain mapping, SEEG, and brain stimulation of persons with intractable epilepsy and other brain diseases/disorders. *Long Term Monitoring: Device use is indicated for up to 29 days.

Source: adtechmedical.com