JXLClass II
Block, Bite
21 CFR 882.5070 / Neurology
JXL is the FDA product code for Block, Bite, a class II device type, regulated under 21 CFR 882.5070. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JXL
- Device name
- Block, Bite
- Regulation
- 21 CFR 882.5070
- 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
- 28
- Ingested recalls
- 0
Clearances, product code JXL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 2 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1999 | 1 |
| 2005 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code JXL| Applicant | Clearances |
|---|---|
| Scott All-Sports, Inc. | 2 |
| Somatics, LLC | 2 |
| United States Endoscopy Group, Inc. | 2 |
| B & B Medical Technologies, Inc. | 1 |
| Brimms, Inc. | 1 |
| Cherry Plastics, Inc. | 1 |
| Dupaco, Inc. | 1 |
| Dyna-Med | 1 |
| Episafe Medical Devices, Ltd. | 1 |
| Ethox Corp. | 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.