Ad-Tech Subdural Electrode

by Ad-Tech Medical Instrument Corp.

510(k) K970587

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) K970587↗

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	NumberK970587	Date9 May 1997Cleared	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Withdrawn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)

510(k) Number: K970587
FDA product code: GYC
FDA applicant: Ad-Tech Medical Instrument Corp

Device class: Class II
Regulation: 21 CFR Part 882.1310
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Ad-Tech Subdural Electrode is a cortical electrode designed for intracranial monitoring and recording of electrical activity in the brain. It is classified as a Class II medical device and is used to facilitate neurological assessments, particularly in epilepsy and brain disorder evaluations.

This device is supplied sterile for single-use and is intended for surgical implantation to enable long-term EEG monitoring, typically up to 29 days. It is available in platinum or stainless steel configurations with either numbered or non-numbered contacts, featuring 10mm contact spacing and an 8mm width. The electrode adheres to FDA clearance (510K) and regulatory standards for neurological applications, including MRI safety considerations as specified in regulation number 882.1310.

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