LGHClass I
Instrument, Cast Removal, Ac-Powered
21 CFR 888.5960 / Orthopedic
LGH is the FDA product code for Instrument, Cast Removal, Ac-Powered, a class I device type, regulated under 21 CFR 888.5960. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LGH
- Device name
- Instrument, Cast Removal, Ac-Powered
- Regulation
- 21 CFR 888.5960
- Device class
- Class I
- Review panel
- Orthopedic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 0
Clearances, product code LGH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1987 | 4 |
| 1989 | 2 |
| 1990 | 1 |
| 1994 | 1 |
Applicants with the most clearances
Product code LGH| Applicant | Clearances |
|---|---|
| Martin Medical | 4 |
| Black & Decker(Tm) | 1 |
| Bremer Mfg. & Tool Co., Inc. | 1 |
| Buckman Co., Inc. | 1 |
| Carapace, Inc. | 1 |
| Johnson & Johnson Professionals, 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.
