Home / Device Classification / LYA

LYA — Splint, Intranasal Septal Class I

FDA Device Classification

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-NumberApplicantDevice NameDate
K243655spirairTurbAlignJuly 11, 2025
K230142biomed entEpi-Stop Nasal Gel/epistaxis packMarch 22, 2023
K213153spiwaySPIWay Endonasal Access GuideOctober 27, 2021
K202623medtronic xomedNovapak Nasal Sinus Packing and StentDecember 8, 2020
K181696gyrus acmiChitoZolveNovember 30, 2018
K180141spiwaySPIWay Endonasal Access GuideFebruary 16, 2018
K170913sts medicalComposite Removable Sinus Stent SystemDecember 15, 2017
K172179chitogelChitogel Endoscopic Sinus Surgery KitOctober 17, 2017
K153686spiwaySPIWay Endonasal Access GuideJanuary 28, 2016
K141816polyganics b.vHEMOPOREOctober 23, 2014
K141704medtronicNOVASHIELD INJECTABLE NASAL PACKING AND STENTOctober 6, 2014
K141423polyganics b.vNASOPORE-FDAugust 7, 2014
K140992arthrocare corporationARTHROCARE NASASTENT CMC NASAL DRESSINGJune 16, 2014
K132721spiwaySPIWAY ENDONASAL ACCESS GUIDEJanuary 29, 2014
K130354entrigue surgicalMEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)May 29, 2013
K122494hemostasisPOSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTMarch 27, 2013
K113585cogent therapeuticsNASAL/EPISTAXIS PACKApril 25, 2012
K092401sinexusSINEXUS SINUS STENT GEN 2, MODEL 1999-25November 17, 2009
K082276synthemedSYNTHEMED DEVICENovember 18, 2008
K080247z-medica corporationQUIKCLOT NOSEBLEEDFebruary 27, 2008