Quikclot Nosebleed
FDA 510(k) K080247 · Z-Medica Corporation
510(k) numberK080247
Submission
- Device name
- Quikclot Nosebleed
- Applicant
- Z-Medica Corporation
Wallingford, CT, US - Received
- January 31, 2008
- Decision date
- February 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYA – Splint, Intranasal Septal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4780
- Specialty
- Ear, Nose, Throat
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| K213153 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 10/27/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | Medtronic Xomed | 12/08/2020SE |
| K181696 | ChitoZolveLYA · Traditional | Gyrus Acmi, Inc. | 11/30/2018SE |
| K180141 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 02/16/2018SE |
| K170913 | Composite Removable Sinus Stent SystemLYA · Traditional | Sts Medical | 12/15/2017SE |
| K172179 | Chitogel Endoscopic Sinus Surgery KitLYA · Traditional | Chitogel, Ltd. | 10/17/2017SE |
| K153686 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 01/28/2016SE |
| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
More from Polyganics B.V.,
| 510(k) | Device | Decision |
|---|---|---|
| K220971 | QuikClot Control+ Hemostatic DressingPOD · Traditional | 12/14/2022SE |
| K200167 | QuikClot Control+POD · Traditional | 04/23/2020SE |
| K181641 | QuikClot RadialQSY · Traditional | 12/24/2018SE |
| K140757 | D2 Hemostantic DressingQSY · Traditional | 07/17/2014SE |
| K123387 | Quikclot Hemostatic DressingQSY · Traditional | 04/12/2013SE |
| K120782 | Interventional Hemostatic BandageQSY · Traditional | 03/20/2013SE |
| K090620 | Quikclot Inteventional, Model P/N 182QSY · Traditional | 04/08/2009SE |
| K072474 | Quikclot ExQSY · Traditional | 10/16/2007SE |
| K070010 | Quikclot Sport and Quikclot Sport SilverQSY · Special | 01/25/2007SE |
| K061767 | Quikclot 1ST Response & Quikclot Acs+QSY · Special | 07/19/2006SE |
Questions and answers
When was Quikclot Nosebleed cleared by the FDA?
Quikclot Nosebleed (K080247) received a 510(k) decision of Substantially Equivalent on February 27, 2008, 27 days after the submission was received.
What is the product code of K080247?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.