Product code GYB
- Device name
- Media, Electroconductive
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1275
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-04-08 |
| K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc. | 2023-09-15 |
| K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | 2022-12-13 |
| K221724 | Conductive Gel | Tone-A-Matic International, Inc. | 2022-09-23 |
| K212325 | EEG-acp | Somnomedics GmbH | 2022-06-15 |
| K212326 | AC Cream - Conductive paste | Spes Medica Srl | 2021-12-01 |
| K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty , Ltd. | 2021-11-08 |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | 2020-11-25 |
| K191975 | Elefix V Paste for EEG & EMG | Nihon Kohden Corporation | 2020-02-07 |
| K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020-01-17 |
| K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019-07-19 |
| K161715 | EndyGel | Endymed Medical, Ltd. | 2017-02-07 |
| K161654 | NuFACE Gel Primer | Carol Cole Company | 2016-12-30 |
| K111717 | ELECTRO-GEL | Electro-Cap Intl., Inc. | 2012-01-05 |
| K032239 | THERA-CREAM, MODEL TCT004 | Prizm Medical, Inc. | 2004-07-30 |
| K033052 | CONDUCTIVE EEG ELECTROLYTE | Compumedics USA, Ltd. | 2003-12-17 |
| K030887 | LEKTROGEL, MODEL LK3001 | Inmed Ltda. | 2003-06-13 |
| K022494 | HOME CARE JELLY | Roc Chinese-European Industrial Research Society | 2002-12-02 |
| K022006 | CONDUCTIVE GEL | The Dezac Group | 2002-09-13 |
| K003924 | MAVIDON MEDICAL ELECTRODE JELLY | Mavidon Medical Products | 2001-08-24 |
| K002832 | CONDUCTIVE GEL FOR ULTRASOUND | Skylark Device & Systems Co., Ltd. | 2001-08-06 |
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | Chester Labs, Inc. | 2000-06-29 |
| K983964 | BATCH #6060 CONDUCTIVE GEL | Skylark Device Co., Ltd. | 1998-12-09 |
| K970694 | MODEL 1700, HYDRO PREP | Physiometrix, Inc. | 1997-05-14 |
| K964737 | HYDROPREP GEL | D.O. Weaver Co. | 1997-03-19 |
| K962681 | ECOGEL 300 TENS GEL | Eco-Med Pharmaceuticals, Inc. | 1996-10-04 |
| K955597 | MEDI-TRACE DEFIB PADS | Graphic Controls Corp. | 1996-07-09 |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | Chester Labs, Inc. | 1996-05-07 |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | Chester Labs, Inc. | 1996-05-07 |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | Chester Labs, Inc. | 1995-11-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16971292006746 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | 2024-08-13 |
| 16971292006739 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | 2024-08-13 |
| B311PEHTNPDS20 | PURE ENRICHMENT | BEAR DOWN CONSULTING | 2023-12-14 |
| 10855683006910 | BrainScope | PARKER LABORATORIES INC | 2023-09-18 |
| 10855683006545 | Ultradrape | PARKER LABORATORIES INC | 2023-09-18 |
| 10855683006958 | Alpha-Stim | PARKER LABORATORIES INC | 2023-09-12 |
| 10855683006941 | Alpha-Stim | PARKER LABORATORIES INC | 2023-09-12 |
| 10855683006897 | Alpha-Stim | PARKER LABORATORIES INC | 2022-03-01 |
| 10855683006880 | Alpha-Stim | PARKER LABORATORIES INC | 2022-03-01 |
| 18054655023661 | AC Cream - Conductive Paste | SPES MEDICA SPA | 2021-12-22 |
| 10855683006873 | Soterixmedical HD-Gel | PARKER LABORATORIES INC | 2021-11-22 |
| 30891893002278 | Ten20 Conductive Paste | D. O. WEAVER AND COMPANY | 2021-10-06 |
| 10855683006569 | SIGNASPRAY | PARKER LABORATORIES INC | 2017-07-05 |
| 10841983102896 | Elefix | NIHON KOHDEN AMERICA, INC. | 2017-05-26 |
| 10855683006392 | REDUX | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006194 | SPECTRA | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006200 | SPECTRA | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006217 | SIGNAGEL | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006224 | SIGNAGEL | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006231 | SIGNACREME | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006262 | SIGNASPRAY | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006330 | TENSIVE | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006385 | REDUX | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006408 | REDUX | PARKER LABORATORIES INC | 2016-12-19 |
| 10884521643161 | Covidien | Cardinal Health, Inc. | 2016-09-24 |
| 10816843022645 | Rochester | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 30707387284733 | 3M™ | 3M COMPANY | 2016-09-24 |
| 30707387284740 | 3M™ | 3M COMPANY | 2016-09-24 |
| 10816843022683 | Rochester | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843022669 | Rochester | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |