KIJClass I
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
21 CFR 878.4820 / General, Plastic Surgery
KIJ is the FDA product code for Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- KIJ
- Device name
- Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Regulation
- 21 CFR 878.4820
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 29
- Ingested recalls
- 10
Clearances, product code KIJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 1 |
| 1980 | 5 |
| 1982 | 2 |
| 1985 | 3 |
| 1986 | 1 |
| 1988 | 2 |
| 1994 | 5 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2016 | 1 |
Applicants with the most clearances
Product code KIJ| Applicant | Clearances |
|---|---|
| Black & Decker(Tm) | 5 |
| Dyonics, Inc. | 3 |
| Aeg Power Tool Corp. | 2 |
| Jeil Medical Corporation | 2 |
| 3M Company | 1 |
| Acu Med, Inc. | 1 |
| Arthrex GmbH | 1 |
| Bio-Rad | 1 |
| Bowen & Company, Inc. | 1 |
| Implant Resource 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.
