Porex Nostril Retainers
FDA 510(k) K981374 · Porex Surgical, Inc.
510(k) numberK981374
Submission
- Device name
- Porex Nostril Retainers
- Applicant
- Porex Surgical, Inc.
College Park, GA, US - Received
- April 16, 1998
- Decision date
- July 2, 1998
- 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
Other 510(k)s with product code LYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
More from Polyganics B.V.,
| 510(k) | Device | Decision |
|---|---|---|
| K102184 | Medpor Contain Can ImplantNPK · Traditional | 01/07/2011SE |
| K101835 | Medpor Fixation System-Cranial, Models 80080, 80079HBW · Traditional | 12/03/2010SE |
| K091807 | Medpor Fixation SystemJEY · Traditional | 06/28/2010SE |
| K091120 | Medpor Contain ImplantNPK · Traditional | 03/19/2010SE |
| K083621 | Medpor Customized Surgical ImplantJOF · Traditional | 02/03/2009SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | 08/08/2007SE |
| K052297 | Porex Electrosurgery NeedleGEI · Traditional | 03/28/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | 07/16/2004SE |
| K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshFTM · Traditional | 06/30/2004SE |
| K021357 | Medpor Plus Orbital Volume Replacement ImpantHPZ · Traditional | 08/05/2002SE |
Questions and answers
When was Porex Nostril Retainers cleared by the FDA?
Porex Nostril Retainers (K981374) received a 510(k) decision of Substantially Equivalent on July 2, 1998, 77 days after the submission was received.
What is the product code of K981374?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.