FDA Product Code
FDA Product Code KAM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | 2011-10-07 | Special | PDF ↗ |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2010-03-03 | Special | PDF ↗ |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2009-01-29 | Traditional | PDF ↗ |
| K072891 | SINUS SPACER | Acclarent, Inc. | 2008-03-19 | Traditional | PDF ↗ |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | Acclarent, Inc. | 2008-03-11 | Traditional | PDF ↗ |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | 2007-09-28 | Traditional | PDF ↗ |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | 2006-09-15 | Traditional | PDF ↗ |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | 2006-05-05 | Special | PDF ↗ |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | 2005-04-27 | Traditional | PDF ↗ |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | 2000-02-08 | Traditional | PDF ↗ |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Atos Medical AB | 1995-02-21 | Traditional | PDF ↗ |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | Atos Medical AB | 1993-01-21 | Traditional | PDF ↗ |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | Micromedics, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | Atos Medical AB | 1990-06-06 | Traditional | PDF ↗ |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | Xomed, Inc. | 1982-01-12 | Traditional | PDF ↗ |
Product code KAM · Class I · General, Plastic Surgery. Data: openFDA.