Conductive EEG Electrolyte
510(k) K033052
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033052 | Date17 Dec 2003 | StatusActive |
Official records
- FDA 510(k) database K033052
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GYB
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1275
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Conductive EEG Electrolyte is an electroconductive medium designed for use in electroencephalography (EEG) recordings. It facilitates the transmission of electrical signals between EEG electrodes and the scalp, ensuring accurate and reliable brainwave measurements during neurological assessments.
This product is supplied as a gel or paste and is intended for single-use applications in clinical settings. It is classified under 21 CFR 882.1275 and has received FDA 510(k) clearance (K033052) as substantially equivalent to a predicate device. The product code assigned is GYB, and it is regulated for use in neurology procedures.
Devices cleared under K033052
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Compumedics Quik-Gel Quik-Gel Electrolyte | 92000014 / Quik-Gel Electrolyte | 09342451003447 | — | On the market |
| Compumedics Quik-Gel Quik-Gel Electrolyte | 92000015 / Quik-Gel Electrolyte | 09342451003430 | — | On the market |
| Compumedics Quik-Gel Quik-Gel Electrolyte | 92000016 / Quik-Gel Electrolyte | 09342451003423 | — | On the market |
| Compumedics Quik-Gel Quik-Gel Electrolyte | 92000017 / Quik-Gel Electrolyte | 09342451003416 | — | On the market |
Similar devices
Other devices filed under FDA product code GYB (Media, Electroconductive).
- GRAHAM-FIELD SALINE ELECTROLYTE GEL by Chester Labs, Inc.
- ZEE ELECTRODE-GEL by Zee Medical Products Co., Inc.
- Jmoon Conductive Gel by SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD
- CONDUCTIVITY GEL by Futuremed Div. of Future Impex Corp.
- LIQUA-SONIC GEL by Chester Labs, Inc.
- ELECTRO-GEL by ELECTRO-CAP INTL., INC.
- NuFACE Gel Primer by Carol Cole Company
- ECA GEL by Vanaray Laboratories, Inc.
- EndyGel by ENDYMED MEDICAL LTD
- Tech Dots - Adhesive and conductive gel by Spes Medica Srl