FDA Product Code GYB: Media, Electroconductive
Leading manufacturers include Spes Medica Srl, Nihon Kohden Corporation and Guangzhou Xinbo Electronic Co., Ltd..
69
Total
69
Cleared
151d
Avg days
1977
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
124d
recently vs 151d historically
FDA 510(k) Cleared Media, Electroconductive Devices (Product Code GYB)
69 devices
Cleared
Apr 08, 2025
Jmoon Conductive Gel
Shenzhen Ulike Smart Electronics Co., Ltd.
Neurology
124d
Cleared
Sep 15, 2023
Avologi Gel Primer (Model: Av25)
Premier North America, Inc.
Neurology
550d
Cleared
Dec 13, 2022
Conductive Gel
Top-Rank Health Care Co., Ltd.
Neurology
90d
Cleared
Sep 23, 2022
Conductive Gel
Tone-A-Matic International, Inc.
Neurology
101d
Cleared
Jun 15, 2022
EEG-acp
Somnomedics GmbH
Neurology
324d
Cleared
Dec 01, 2021
AC Cream - Conductive paste
Spes Medica Srl
Neurology
128d
Cleared
Nov 08, 2021
GT5 conductive & abrasive gel
Wuhan Greentek Pty , Ltd.
Neurology
68d
Cleared
Nov 25, 2020
DR-HO'S Electro Therapy Conductive Gel
Guangzhou Xinbo Electronic Co., Ltd.
Neurology
280d
Cleared
Feb 07, 2020
Elefix V Paste for EEG & EMG
Nihon Kohden Corporation
Neurology
198d
Cleared
Jan 17, 2020
SAC2 - Electrode Cream
Spes Medica Srl
Neurology
119d
Cleared
Jul 19, 2019
Tech Dots - Adhesive and conductive gel
Spes Medica Srl
Neurology
190d
About Product Code GYB - Regulatory Context
510(k) Submission Activity
69 total 510(k) submissions under product code GYB since 1977, with 69 receiving FDA clearance (average review time: 151 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - GYB Product Code
Recent submissions under GYB have taken an average of 124 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
GYB devices are reviewed by the Neurology panel. Browse all Neurology devices →