Maxill-Air Sinus Ventilation Tube
FDA 510(k) K813474 · Xomed, Inc.
510(k) numberK813474
Submission
- Device name
- Maxill-Air Sinus Ventilation Tube
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- December 1, 1981
- Decision date
- January 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAM – Cannula, Sinus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KAM
| 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 |
More from Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Maxill-Air Sinus Ventilation Tube cleared by the FDA?
Maxill-Air Sinus Ventilation Tube (K813474) received a 510(k) decision of Substantially Equivalent on January 12, 1982, 42 days after the submission was received.
What is the product code of K813474?
The FDA product code is KAM – Cannula, Sinus, a Class I (low risk) device regulated under 21 CFR 878.4800.