GFDClass I
Dermatome
21 CFR 878.4820 / General, Plastic Surgery
GFD is the FDA product code for Dermatome, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 22 recalls.
Classification record
- Product code
- GFD
- Device name
- Dermatome
- 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
- 12
- Ingested recalls
- 22
Clearances, product code GFD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 4 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 2 |
Applicants with the most clearances
Product code GFD| Applicant | Clearances |
|---|---|
| Aesculap Inc | 1 |
| Davol, Inc. | 1 |
| Depuy Intl., Ltd. | 1 |
| Downs Surgical, Ltd. | 1 |
| Dsp Worldwide | 1 |
| Mattioli Engineering Corp. | 1 |
| Mecron Medical Products, Inc. | 1 |
| Mri Ventures, Inc. | 1 |
| Padgett Instruments, Inc. | 1 |
| Precision Modified Devices | 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.
