# K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000)

- Pathway: 510(k) (Traditional)
- Applicant: Microrecording Systems Consultants, LLC
- Decided: Jun 9, 1999 after 70 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 4 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991522: Microtargeting Electrode (2000), 17 descendants of its own
- K033173: Micro Targeting Electrode (2004), 16 descendants of its own
- K041604: Macro-Micro Depth Electrode (2004), 12 descendants of its own
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (2006), 11 descendants of its own
- K012850: Recording and Stimulating Electrode (2001), 6 descendants of its own

## Indications for use
The intended use of our uEEG™ Pro System 5000 is for temporary recording of intracranial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials. Our uEEG™ Pro System 5000 is intended to be used during neurosurgical procedures for an amount of time that is sufficient to obtain the necessary information. During recording procedures, the required time duration is between 30 minutes to several hours. During this time, an electrode will be in continuous contact with tissue for no longer than about 30 minutes. The uEEG™ Pro System 5000 is designed for use in operating rooms appropriate for functional neurosurgery. (Warning Labels are attached to machine indicating that it is not to be used in the presence of flammable anesthetics). uEEG™ Pro System 5000 is indicated for use during intraoperative intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.

Source page: https://510kreport.com/device/K991077
Methodology: https://510kreport.com/methodology