GYB — Media, Electroconductive Class II
FDA product code GYB covers "Media, Electroconductive", a Class II medical device regulated under 21 CFR 882.1275. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GYB
- Device Class
- Class II
- Regulation Number
- 882.1275
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243749 | shenzhen ulike smart electronics co | Jmoon Conductive Gel | April 8, 2025 |
| K220735 | premier north america | Avologi Gel Primer (Model: Av25) | September 15, 2023 |
| K222770 | top-rank health care co | Conductive Gel | December 13, 2022 |
| K221724 | tone-a-matic international | Conductive Gel | September 23, 2022 |
| K212325 | somnomedics | EEG-acp | June 15, 2022 |
| K212326 | spes medica | AC Cream - Conductive paste | December 1, 2021 |
| K212787 | wuhan greentek pty | GT5 conductive & abrasive gel | November 8, 2021 |
| K200402 | guangzhou xinbo electronic co | DR-HO'S Electro Therapy Conductive Gel | November 25, 2020 |
| K191975 | nihon kohden corporation | Elefix V Paste for EEG & EMG | February 7, 2020 |
| K192606 | spes medica | SAC2 - Electrode Cream | January 17, 2020 |
| K190050 | spes medica | Tech Dots - Adhesive and conductive gel | July 19, 2019 |
| K161715 | endymed medical | EndyGel | February 7, 2017 |
| K161654 | carol cole | NuFACE Gel Primer | December 30, 2016 |
| K111717 | electro-cap intl | ELECTRO-GEL | January 5, 2012 |
| K032239 | prizm medical | THERA-CREAM, MODEL TCT004 | July 30, 2004 |
| K033052 | compumedics usa | CONDUCTIVE EEG ELECTROLYTE | December 17, 2003 |
| K030887 | inmed ltda | LEKTROGEL, MODEL LK3001 | June 13, 2003 |
| K022494 | roc chinese-european industrial research society | HOME CARE JELLY | December 2, 2002 |
| K022006 | dezac group | CONDUCTIVE GEL | September 13, 2002 |
| K003924 | mavidon medical products | MAVIDON MEDICAL ELECTRODE JELLY | August 24, 2001 |