Product code KAM
- Device name
- Cannula, Sinus
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | 2011-10-07 |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2010-03-03 |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2009-01-29 |
| K072891 | SINUS SPACER | Acclarent, Inc. | 2008-03-19 |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | Acclarent, Inc. | 2008-03-11 |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | 2007-09-28 |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | 2006-09-15 |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | 2006-05-05 |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | 2005-04-27 |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | 2000-02-08 |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | 1997-09-29 |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Atos Medical AB | 1995-02-21 |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | 1993-05-18 |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | Atos Medical AB | 1993-01-21 |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | Micromedics, Inc. | 1991-12-20 |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | Atos Medical AB | 1990-06-06 |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | Xomed, Inc. | 1982-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08904461006835 | OSSEOUS Suction Tube for Sinus-Disposable | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904461006842 | OSSEOUS Suction Tube for Sinus-Disposable | EON MEDITECH PRIVATE LIMITED | 2024-07-03 |
| 08904428724062 | OSSEOUS Suction tubes for Sinus | EON MEDITECH PRIVATE LIMITED | 2024-06-25 |
| 08906039313093 | OSSEOUS Suction Tubes for Nose Disposable | EON MEDITECH PRIVATE LIMITED | 2024-06-25 |
| 08906039313697 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313673 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313666 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313598 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313574 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313567 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313079 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039313062 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312997 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312980 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312973 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312966 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312942 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312898 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312850 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312799 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312782 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08904461010979 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-21 |
| 08906039312775 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312751 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312744 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312591 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312584 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312577 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312560 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |
| 08906039312546 | OSSEOUS | EON MEDITECH PRIVATE LIMITED | 2024-06-12 |