LYA — Splint, Intranasal Septal Class I
FDA product code LYA covers "Splint, Intranasal Septal", a Class I medical device regulated under 21 CFR 874.4780. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYA
- Device Class
- Class I
- Regulation Number
- 874.4780
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243655 | spirair | TurbAlign | July 11, 2025 |
| K230142 | biomed ent | Epi-Stop Nasal Gel/epistaxis pack | March 22, 2023 |
| K213153 | spiway | SPIWay Endonasal Access Guide | October 27, 2021 |
| K202623 | medtronic xomed | Novapak Nasal Sinus Packing and Stent | December 8, 2020 |
| K181696 | gyrus acmi | ChitoZolve | November 30, 2018 |
| K180141 | spiway | SPIWay Endonasal Access Guide | February 16, 2018 |
| K170913 | sts medical | Composite Removable Sinus Stent System | December 15, 2017 |
| K172179 | chitogel | Chitogel Endoscopic Sinus Surgery Kit | October 17, 2017 |
| K153686 | spiway | SPIWay Endonasal Access Guide | January 28, 2016 |
| K141816 | polyganics b.v | HEMOPORE | October 23, 2014 |
| K141704 | medtronic | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | October 6, 2014 |
| K141423 | polyganics b.v | NASOPORE-FD | August 7, 2014 |
| K140992 | arthrocare corporation | ARTHROCARE NASASTENT CMC NASAL DRESSING | June 16, 2014 |
| K132721 | spiway | SPIWAY ENDONASAL ACCESS GUIDE | January 29, 2014 |
| K130354 | entrigue surgical | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) | May 29, 2013 |
| K122494 | hemostasis | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | March 27, 2013 |
| K113585 | cogent therapeutics | NASAL/EPISTAXIS PACK | April 25, 2012 |
| K092401 | sinexus | SINEXUS SINUS STENT GEN 2, MODEL 1999-25 | November 17, 2009 |
| K082276 | synthemed | SYNTHEMED DEVICE | November 18, 2008 |
| K080247 | z-medica corporation | QUIKCLOT NOSEBLEED | February 27, 2008 |