Conductivity Gel W/Potassium Chloride

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

510(k) Number

K770622 ↗

FDA Product Code

GYB

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Conductivity Gel with Potassium Chloride used for?

  This gel is designed to enhance electrical conductivity between electrodes and skin during electrophysiological procedures. It contains potassium chloride to improve signal transmission, ensuring low-resistance contact for accurate readings in tests like electroencephalography (EEG) or electromyography (EMG). This helps minimize artifacts and ensures reliable neurological assessments.

• How is the Conductivity Gel with Potassium Chloride supplied?

  The gel is supplied as a sterile, single-use product, packaged for direct application to the skin prior to electrode placement. This ensures hygiene and prevents cross-contamination in clinical settings.

• Is the Conductivity Gel with Potassium Chloride reusable or single-use?

  This gel is explicitly designed for single-use only. Its sterile packaging and intended clinical application make reuse unsafe and unsuitable, as it could compromise sterility and patient safety.

• What storage conditions should be followed for this gel?

  The gel should be stored under standard sterile medical gel conditions. This typically means keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.

• Does this gel have any specific MRI safety information?

  No MRI safety information is specified for this Conductivity Gel with Potassium Chloride. Clinicians should verify compatibility with MRI equipment and protocols before use in MRI environments.