Model 4310 PSARRAY2 EEG Electrode

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

510(k) Number

K020670 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Model 4310 PSArray² EEG Electrode used for?

  The Model 4310 PSArray² EEG Electrode is designed specifically for recording electroencephalography (EEG) signals during clinical neurology procedures. Its six electrodes are positioned at standardized frontal scalp locations (F7, Fp1, FpZ′, FpZ, Fp2, and F8) to enable high-density EEG monitoring, which helps improve the accuracy and precision of scalp electrode placement for diagnostic purposes.

• How is the Model 4310 PSArray² EEG Electrode supplied?

  The device is supplied as a single-use, disposable electrode array. Each electrode is mounted on polyethylene foam with a pressure-sensitive adhesive for secure attachment to the scalp. It comes packaged individually in pouches, with 25 pouches per box and 4 boxes per case, ensuring easy handling and sterility for clinical use.

• Is the Model 4310 PSArray² EEG Electrode sterile?

  The available data does not specify whether the Model 4310 PSArray² EEG Electrode is sterile or requires additional sterilization procedures. However, as it is a single-use, disposable device, it is packaged in pouches to maintain cleanliness and reduce contamination risk during use.

• Can the Model 4310 PSArray² EEG Electrode be reused?

  No, the Model 4310 PSArray² EEG Electrode is explicitly designed for single-use only. Reusing the device could compromise signal accuracy, electrode integrity, and patient safety due to potential contamination or degradation of the adhesive and gel over time.

• What regulatory approval does the Model 4310 PSArray² EEG Electrode hold?

  The Model 4310 PSArray² EEG Electrode holds FDA 510(k) clearance under the classification of Special, with the clearance number K020670. It was reviewed by the Neurology Devices Advisory Committee and is classified under product code GXY, indicating its intended use in neurology-related diagnostic procedures.