KAMClass I
Cannula, Sinus
21 CFR 878.4800 / General, Plastic Surgery
KAM is the FDA product code for Cannula, Sinus, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- KAM
- Device name
- Cannula, Sinus
- 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
- 19
- Ingested recalls
- 2
Clearances, product code KAM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1995 | 3 |
| 1997 | 1 |
| 2000 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
Applicants with the most clearances
Product code KAM| Applicant | Clearances |
|---|---|
| Acclarent Inc | 8 |
| Atos Medical AB | 3 |
| Micromedics, Inc. | 2 |
| Smith & Nephew Richards, Inc. | 2 |
| Xomed, Inc. | 2 |
| Boston Medical Products, Inc. | 1 |
| Xomed, 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.
