FTDClass II
Lamp, Surgical
21 CFR 878.4580 / General, Plastic Surgery
FTD is the FDA product code for Lamp, Surgical, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 49 recalls.
Classification record
- Product code
- FTD
- Device name
- Lamp, Surgical
- Regulation
- 21 CFR 878.4580
- Device class
- Class II
- 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
- 29
- Ingested recalls
- 49
Clearances, product code FTD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 2001 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2013 | 3 |
Applicants with the most clearances
Product code FTD| Applicant | Clearances |
|---|---|
| AtriCure, Inc. | 2 |
| Burton Medical Products Corp. | 2 |
| Engineered Medical Solutions Co., LLC | 2 |
| Fiber Optics Engineering, Inc. | 2 |
| Stryker Corp. | 2 |
| Affiliated Hospital Products, Inc. | 1 |
| Alm Surgical Equipment, Inc. | 1 |
| American Sterilizer Co. | 1 |
| Amsco Co. | 1 |
| Drager Medical B.V. | 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.