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Cortical Mapping Unit, Model CMU

by Ad-Tech Medical Instrument Corp.

510(k) K992194

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 NumberK992194 Date13 Sep 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  • Withdrawn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
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, 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 Cortical Mapping Unit, Model CMU, is a Cortical Electrode designed for intraoperative recording of cortical surface electroencephalography (EEG) activity. It facilitates real-time monitoring of brain signals during surgical procedures, aiding in the precise localization of brain function and identification of epileptogenic zones or functional areas.

This device is supplied as a reusable medical instrument and is classified under FDA product code GYC as a Class II device with special controls. It is intended for use in neurosurgical settings, where sterile conditions are maintained, and is regulated under the FDA 510(k) clearance (K992194). The unit operates in accordance with 21 CFR 882.1310, adhering to regulatory standards for cortical electrode systems.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of the Cortical Mapping Unit, Model CMU, during neurosurgical procedures?

    The Cortical Mapping Unit, Model CMU, is designed for intraoperative recording of cortical surface electroencephalography (EEG) activity. It helps surgeons monitor brain signals in real-time to precisely identify functional brain areas or epileptogenic zones, ensuring safer and more accurate surgical interventions.

  • Is the Cortical Mapping Unit, Model CMU, intended for single-use or reusable applications?

    The Cortical Mapping Unit, Model CMU, is explicitly supplied as a reusable medical instrument. It is intended for use in sterile neurosurgical settings, where proper cleaning and maintenance protocols must be followed to ensure safety and functionality across multiple procedures.

  • How is the regulatory status of this device determined, and what does that mean for its use?

    The Cortical Mapping Unit, Model CMU, is classified as a Class II device under FDA product code GYC and has received FDA 510(k) clearance (K992194). This means it has been determined to be substantially equivalent to a legally marketed device and is regulated under 21 CFR 882.1310, ensuring it meets specific safety and performance standards for use in neurosurgical settings.

  • What types of surgical settings or specialties is this device intended for?

    The Cortical Mapping Unit, Model CMU, is specifically designed for neurosurgical settings where real-time monitoring of brain activity is critical. Its regulatory filings and advisory committee classification under Neurology confirm its intended use in procedures involving cortical mapping, such as epilepsy surgery or tumor resection, where precise localization of brain function is essential.