GDGClass I
Hook, Surgical, General & Plastic Surgery
21 CFR 878.4800 / General, Plastic Surgery
GDG is the FDA product code for Hook, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- GDG
- Device name
- Hook, 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
- 10
- Ingested recalls
- 7
Clearances, product code GDG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1984 | 2 |
| 1986 | 1 |
| 1989 | 1 |
| 1990 | 1 |
Applicants with the most clearances
Product code GDG| Applicant | Clearances |
|---|---|
| Edward Weck, Inc. | 3 |
| Brimfield Scientific Instruments | 1 |
| Cedar Surgical, Inc. | 1 |
| Humboldt Products | 1 |
| Premier Dental Products Co | 1 |
| United States Surgical, A Division of Tyco Healthc | 1 |
| Xomed, Inc. | 1 |
| Zinnanti Surgical Instruments, 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.
