KAM — Cannula, Sinus Class I
FDA product code KAM covers "Cannula, Sinus", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KAM
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110687 | acclarent | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | October 7, 2011 |
| K093594 | acclarent | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | March 3, 2010 |
| K083574 | acclarent | RELIEVA STRATUS MICROFLOW SPACER | January 29, 2009 |
| K072891 | acclarent | SINUS SPACER | March 19, 2008 |
| K073041 | acclarent | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | March 11, 2008 |
| K071845 | acclarent | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | September 28, 2007 |
| K062458 | acclarent | ETHMOID SINUS SPACER | September 15, 2006 |
| K060974 | acclarent | RELIENT NAVIGATION DEVICE | May 5, 2006 |
| K050340 | micromedics | MICROMEDICS SPHENOID SINUS STENT | April 27, 2005 |
| K994262 | xomed | FRONTAL SINUS TREPHINATION CANNULA | February 8, 2000 |
| K973273 | xomed | XOMED T-STENT, FRONTAL SINUS STENT | September 29, 1997 |
| K951803 | smith and nephew richards | ROSSITER SINUS STENT | May 11, 1995 |
| K951066 | smith and nephew richards | RAINS FRONTAL SINUS STENT | April 4, 1995 |
| K942495 | atos medical | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | February 21, 1995 |
| K922902 | boston medical products | SALMAN SINUS BUTTON | May 18, 1993 |
| K922145 | atos medical | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | January 21, 1993 |
| K912418 | micromedics | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | December 20, 1991 |
| K896630 | atos medical | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | June 6, 1990 |
| K813474 | xomed | MAXILL-AIR SINUS VENTILATION TUBE | January 12, 1982 |