GEYClass I
Motor, Surgical Instrument, Ac-Powered
21 CFR 878.4820 / General, Plastic Surgery
GEY is the FDA product code for Motor, Surgical Instrument, Ac-Powered, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 27 recalls.
Classification record
- Product code
- GEY
- Device name
- Motor, Surgical Instrument, Ac-Powered
- 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
- 41
- Ingested recalls
- 27
Clearances, product code GEY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 4 |
| 1987 | 2 |
| 1988 | 1 |
| 1990 | 2 |
| 1991 | 4 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 6 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 1 |
Applicants with the most clearances
Product code GEY| Applicant | Clearances |
|---|---|
| American Surgical Laser, Inc. | 3 |
| Biomedical Ent., Inc. | 3 |
| Micro Surgical Instruments Corp. | 3 |
| The Anspach Effort, Inc. | 3 |
| Black & Decker(Tm) | 2 |
| Linvatec Corporation | 2 |
| Mcghan Medical Corp. | 2 |
| Micro-Aire Surgical Instruments, Inc. | 2 |
| Mizuho Orthopedic Systems Inc | 2 |
| 3M Company | 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.
