GWLClass II
Amplifier, Physiological Signal
21 CFR 882.1835 / Neurology
GWL is the FDA product code for Amplifier, Physiological Signal, a class II device type, regulated under 21 CFR 882.1835. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- GWL
- Device name
- Amplifier, Physiological Signal
- Regulation
- 21 CFR 882.1835
- 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
- 53
- Ingested recalls
- 4
Clearances, product code GWL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 2 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2001 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 1 |
Applicants with the most clearances
Product code GWL| Applicant | Clearances |
|---|---|
| EB Neuro S.p.A. | 8 |
| G.tec Medical Engineering GmbH | 3 |
| Nihon Kohden America Inc | 3 |
| Blackrock Microsystems | 2 |
| Honeywell, Inc. | 2 |
| Intelligent Hearing Systems Corp. | 2 |
| Neurotronics, LLC | 2 |
| Tms International BV | 2 |
| Allergan | 1 |
| Amplaid USA, Inc. | 1 |
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.