FDA 510(k) Applications for Medical Device Product Code "GYB"
(Media, Electroconductive)

FDA 510(k) Number Applicant Device Name Decision Date
K161654 Carol Cole Company NuFACE Gel Primer 12/30/2016
K944599 CHESTER LABS, INC. GRAHAM-FIELD CONDUCTIVE ECG SPRAY 05/07/1996
K944598 CHESTER LABS, INC. GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL 05/07/1996
K001705 CHESTER LABS, INC. STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF 06/29/2000
K033052 COMPUMEDICS USA, LTD. CONDUCTIVE EEG ELECTROLYTE 12/17/2003
K964737 D.O. WEAVER CO. HYDROPREP GEL 03/19/1997
K962681 ECO-MED PHARMACEUTICALS, INC. ECOGEL 300 TENS GEL 10/04/1996
K111717 ELECTRO-CAP INTL., INC. ELECTRO-GEL 01/05/2012
K161715 EndyMed Medical Ltd. EndyGel 02/07/2017
K955597 GRAPHIC CONTROLS CORP. MEDI-TRACE DEFIB PADS 07/09/1996
K200402 Guangzhou Xinbo Electronic Co., Ltd. DR-HO'S Electro Therapy Conductive Gel 11/25/2020
K030887 INMED LTDA. LEKTROGEL, MODEL LK3001 06/13/2003
K003924 MAVIDON MEDICAL PRODUCTS MAVIDON MEDICAL ELECTRODE JELLY 08/24/2001
K191975 Nihon Kohden Corporation Elefix V Paste for EEG & EMG 02/07/2020
K970694 PHYSIOMETRIX, INC. MODEL 1700, HYDRO PREP 05/14/1997
K220735 Premier North America Inc. Avologi Gel Primer (Model: Av25) 09/15/2023
K032239 PRIZM MEDICAL, INC. THERA-CREAM, MODEL TCT004 07/30/2004
K022494 ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY HOME CARE JELLY 12/02/2002
K002832 SKYLARK DEVICE & SYSTEMS CO., LTD CONDUCTIVE GEL FOR ULTRASOUND 08/06/2001
K983964 SKYLARK DEVICE CO., LTD. BATCH #6060 CONDUCTIVE GEL 12/09/1998
K212325 SOMNOmedics GmbH EEG-acp 06/15/2022
K212326 Spes Medica S.r.l AC Cream - Conductive paste 12/01/2021
K192606 Spes Medica S.r.l. SAC2 - Electrode Cream 01/17/2020
K190050 Spes Medica S.r.l. Tech Dots - Adhesive and conductive gel 07/19/2019
K022006 THE DEZAC GROUP CONDUCTIVE GEL 09/13/2002
K221724 Tone-A-Matic International Inc. Conductive Gel 09/23/2022
K222770 Top-Rank Health Care Co.,Ltd. Conductive Gel 12/13/2022
K212787 Wuhan Greentek Pty Ltd. GT5 conductive & abrasive gel 11/08/2021


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