FZTClass I
Cutter, Surgical
21 CFR 878.4800 / General, Plastic Surgery
FZT is the FDA product code for Cutter, Surgical, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 52 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- FZT
- Device name
- Cutter, Surgical
- 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
- 52
- Ingested recalls
- 6
Clearances, product code FZT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 12 |
| 1978 | 3 |
| 1979 | 6 |
| 1980 | 2 |
| 1982 | 24 |
| 1984 | 2 |
| 1987 | 1 |
| 1989 | 1 |
| 2011 | 1 |
Applicants with the most clearances
Product code FZT| Applicant | Clearances |
|---|---|
| Conphar, Inc. | 21 |
| Dentronix, Inc. | 5 |
| Edward Weck, Inc. | 5 |
| Sea-Pac Trading Corp. | 4 |
| J. Sklar Mfg. Co., Inc. | 2 |
| Laschal Instrument Corp. | 2 |
| Depuy, Inc. | 1 |
| Devco Medical Industries, Inc. | 1 |
| E.M. Adams Co., Inc. | 1 |
| Fred Sammons, 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.
