Hemopore
FDA 510(k) K141816 · Polyganics B.V.,
510(k) numberK141816
Submission
- Device name
- Hemopore
- Applicant
- Polyganics B.V.,
Groningen, NL - Received
- July 7, 2014
- Decision date
- October 23, 2014
- 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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| K243655 | TurbAlignLYA · Traditional | Spirair, Inc. | 07/11/2025SE |
| K230142 | Epi-Stop Nasal Gel/epistaxis packLYA · Traditional | Biomed Ent, Inc. | 03/22/2023SE |
| 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 |
| K141704 | Novashield Injectable Nasal Packing and StentLYA · Traditional | Medtronic, Inc. | 10/06/2014SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141423 | Nasopore-FdLYA · Special | 08/07/2014SE |
| K112267 | Neurolac(R) Nerve GuideJXI · Special | 10/20/2011SE |
| K070715 | Nasopore EarNHB · Traditional | 05/07/2007SE |
| K062540 | Nasopore Ear, Models ND04, ND05KCN · Traditional | 10/18/2006SE |
| K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZzLYA · Traditional | 11/21/2005SE |
| K050573 | Neurolac Nerve GuideJXI · Traditional | 05/04/2005SE |
| K042811 | Vivosorb Sheet, Model FS01FTL · Traditional | 11/08/2004SE |
| K032115 | Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03JXI · Traditional | 10/10/2003SE |
Questions and answers
When was Hemopore cleared by the FDA?
Hemopore (K141816) received a 510(k) decision of Substantially Equivalent on October 23, 2014, 108 days after the submission was received.
What is the product code of K141816?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.