# K992194: Cortical Mapping Unit, Model Cmu

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: Sep 13, 1999 after 76 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Model CE-1 Cortical Electrode: named in the summary without a submission number

## Indications for use
The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required. AD-TECH's CMU, like other cortical mapping instruments, is designed to facilitate the recording of EEG potentials from the surface of the brain during surgery. This EEG information can help guide your progress during tumor resections, epilepsy surgery, etc. This device should only be used by physicians/surgeons trained in the use of cortical mapping devices.

Source page: https://510kreport.com/device/K992194
Methodology: https://510kreport.com/methodology