Cannula, Sinus
FDA product code KAM · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
19510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110687 | Relieva Stratus Pro Microflow Spacer (Frontal)KAM · Special | Acclarent, Inc. | 10/07/2011SE |
| K093594 | Modification to Relieva Stratus Microflow SpacerKAM · Special | Acclarent, Inc. | 03/03/2010SE |
| K083574 | Relieva Stratus Microflow SpacerKAM · Traditional | Acclarent, Inc. | 01/29/2009SE |
| K072891 | Sinus SpacerKAM · Traditional | Acclarent, Inc. | 03/19/2008SE |
| K073041 | Relieva and Relieva Acella Sinus Balloon CatheterKAM · Traditional | Acclarent, Inc. | 03/11/2008SE |
| K071845 | Relieva Luma Sinus Illumination System, Model SIS-100AKAM · Traditional | Acclarent, Inc. | 09/28/2007SE |
| K062458 | Ethmoid Sinus SpacerKAM · Traditional | Acclarent, Inc. | 09/15/2006SE |
| K060974 | Relient Navigation DeviceKAM · Special | Acclarent, Inc. | 05/05/2006SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | Micromedics, Inc. | 04/27/2005SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | Xomed, Inc. | 02/08/2000SE |
| K973273 | Xomed T-Stent, Frontal Sinus StentKAM · Traditional | Xomed, Inc. | 09/29/1997SE |
| K951803 | Rossiter Sinus StentKAM · Traditional | Smith & Nephew Richards, Inc. | 05/11/1995SE |
| K951066 | Rains Frontal Sinus StentKAM · Traditional | Smith & Nephew Richards, Inc. | 04/04/1995SE |
| K942495 | Sinojet Maxillary Sinus Puncture & Irrigation SystemKAM · Traditional | Atos Medical AB | 02/21/1995SE |
| K922902 | Salman Sinus ButtonKAM · Traditional | Boston Medical Products, Inc. | 05/18/1993SE |
| K922145 | Sinoject Maxillary Sinus Puncture & Irrigation SysKAM · Traditional | Atos Medical AB | 01/21/1993SE |
| K912418 | Shikani Middle Meatal Antrostomy Vent TubeKAM · Traditional | Micromedics, Inc. | 12/20/1991SE |
| K896630 | Sinovent Maxillary Sinus Drainage SystemKAM · Traditional | Atos Medical AB | 06/06/1990SE |
| K813474 | Maxill-Air Sinus Ventilation TubeKAM · Traditional | Xomed, Inc. | 01/12/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1740-2015 Class III | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus…Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. | Acclarent, Inc. | 04/28/2015Terminated |
| Z-1639-2013 Class II | - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 -…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |