510(k) K220735
- Device
- Avologi Gel Primer (Model: Av25)
- Applicant
- Premier North America, Inc.
- 510(k) number
- K220735
- Product code
- GYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-15
- Date received
- 2022-03-14
- Regulation
- 882.1275
- Classification name
- Media, Electroconductive
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ellis Tamari
- Address
- 3301 SW 42nd St. Fort Lauderdale FL US 33312 33312
FDA Registration Numbers#
- 3001236514
- 1055808
- 3006315274
- 9613619
- 2080783
- 9611558
- 2245302
- 3027329006
- 9710580
- 3017953405
- 1718791
- 3014236293
- 1626185
- 3013501110
- 3012316249
- 3011534533
- 2011115
- 3006551156
- 3003676119
- 1650946
- 3011310592
- 3023339103
- 3028172072
- 3008085016
- 3007481893
- 3031841433
- 3010515191
- 3042268484
- 3031464228
- 3031757047
- 1528161
- 1000524645
- 3010097863
- 3028011
- 1417592
- 8030229
- 1000150986
- 2212018
- 9611252
- 3016852448
- 3006982887
- 3043013796
- 3042272797
- 3006626283
- 3011721071
- 3012386142
- 3012494290
- 3006258337
- 3036720861
- 3013917867
- 3004146401
- 3010836847
- 3011077581
- 3006459199
- 1017294
- 3013957847
Source Documents#
Other 510(k) Records For Product Code GYB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-04-08 |
| 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 |