GDJClass I
Clamp, Surgical, General & Plastic Surgery
21 CFR 878.4800 / General, Plastic Surgery
GDJ is the FDA product code for Clamp, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- GDJ
- Device name
- Clamp, Surgical, General & Plastic Surgery
- Regulation
- 21 CFR 878.4800
- 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
- 32
- Ingested recalls
- 9
Clearances, product code GDJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 6 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 2016 | 1 |
Applicants with the most clearances
Product code GDJ| Applicant | Clearances |
|---|---|
| Edward Weck, Inc. | 5 |
| Conphar, Inc. | 2 |
| Med General | 2 |
| United States Surgical, A Division of Tyco Healthc | 2 |
| Applied Medical Technologies | 1 |
| Artiberia | 1 |
| Berkeley Bio-Medical, Inc. | 1 |
| Berkeley Medevices | 1 |
| Cordis US Corp. | 1 |
| Dlp, 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.
