GYBClass II
Media, Electroconductive
21 CFR 882.1275 / Neurology
GYB is the FDA product code for Media, Electroconductive, a class II device type, regulated under 21 CFR 882.1275. As of , FDA records hold 69 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- GYB
- Device name
- Media, Electroconductive
- Regulation
- 21 CFR 882.1275
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 69
- Ingested recalls
- 10
Clearances, product code GYB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 3 |
| 1979 | 4 |
| 1980 | 8 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 1 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code GYB| Applicant | Clearances |
|---|---|
| Vanaray Laboratories, Inc. | 7 |
| Chester Labs, Inc. | 5 |
| Graphic Controls Corp. | 5 |
| Parker Laboratories, Inc. | 4 |
| Cadwell Laboratories, Inc. | 3 |
| Spes Medica S.P.A | 3 |
| Futuremed Div. of Future Impex Corp. | 2 |
| Henley Intl. | 2 |
| Nihon Kohden America Inc | 2 |
| Suzuken Co., Ltd. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.