Relieva Luma Sinus Illumination System, Model SIS-100A
FDA 510(k) K071845 · Acclarent, Inc.
510(k) numberK071845
Submission
- Device name
- Relieva Luma Sinus Illumination System, Model SIS-100A
- Applicant
- Acclarent, Inc.
Rmenlo Park, CA, US - Received
- July 5, 2007
- Decision date
- September 28, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KAM – Cannula, Sinus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| 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 |
| 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 |
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Questions and answers
When was Relieva Luma Sinus Illumination System, Model SIS-100A cleared by the FDA?
Relieva Luma Sinus Illumination System, Model SIS-100A (K071845) received a 510(k) decision of Substantially Equivalent on September 28, 2007, 85 days after the submission was received.
What is the product code of K071845?
The FDA product code is KAM – Cannula, Sinus, a Class I (low risk) device regulated under 21 CFR 878.4800.