GXRClass II
Cover, Burr Hole
21 CFR 882.5250 / Neurology
GXR is the FDA product code for Cover, Burr Hole, a class II device type, regulated under 21 CFR 882.5250. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- GXR
- Device name
- Cover, Burr Hole
- Regulation
- 21 CFR 882.5250
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 29
- Ingested recalls
- 1
Clearances, product code GXR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1992 | 1 |
| 1996 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2007 | 1 |
| 2010 | 2 |
| 2013 | 4 |
| 2014 | 2 |
| 2016 | 2 |
| 2018 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code GXR| Applicant | Clearances |
|---|---|
| Neos Surgery S.L. | 4 |
| Synthes (USA) Products LLC | 4 |
| Aesculap Inc | 2 |
| Neuropace | 2 |
| Ossdsign | 2 |
| Abbott Medical | 2 |
| Biomet Microfixation | 1 |
| Chendu Medart Medical Scientific Co., Ltd. | 1 |
| Holter-Hausner Intl. | 1 |
| Image-Guided Neurologics, 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.