LYA · Class I · 21 CFR 874.4780

FDA Product Code LYA: Splint, Intranasal Septal

Leading manufacturers include Spiway, LLC, Boston Medical Products, Inc. and Polyganics B.V.,.

46
Total
46
Cleared
96d
Avg days
1983
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 227d recently vs 93d historically

FDA 510(k) Cleared Splint, Intranasal Septal Devices (Product Code LYA)

46 devices
1–24 of 46
Cleared Jul 11, 2025
TurbAlign
K243655
Spirair, Inc.
Ear, Nose, Throat · 227d
Cleared Mar 22, 2023
Epi-Stop Nasal Gel/epistaxis pack
K230142
Biomed Ent, Inc.
Ear, Nose, Throat · 63d
Cleared Oct 27, 2021
SPIWay Endonasal Access Guide
K213153
Spiway, LLC
Ear, Nose, Throat · 29d
Cleared Dec 08, 2020
Novapak Nasal Sinus Packing and Stent
K202623
Medtronic Xomed
Ear, Nose, Throat · 89d
Cleared Nov 30, 2018
ChitoZolve
K181696
Gyrus Acmi, Inc.
Ear, Nose, Throat · 156d
Cleared Feb 16, 2018
SPIWay Endonasal Access Guide
K180141
Spiway, LLC
Ear, Nose, Throat · 29d
Cleared Dec 15, 2017
Composite Removable Sinus Stent System
K170913
Sts Medical
Ear, Nose, Throat · 262d
Cleared Oct 17, 2017
Chitogel Endoscopic Sinus Surgery Kit
K172179
Chitogel, Ltd.
Ear, Nose, Throat · 90d
Cleared Jan 28, 2016
SPIWay Endonasal Access Guide
K153686
Spiway, LLC
Ear, Nose, Throat · 36d
Cleared Oct 23, 2014
HEMOPORE
K141816
Polyganics B.V.,
Ear, Nose, Throat · 108d
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704
Medtronic, Inc.
Ear, Nose, Throat · 104d
Cleared Aug 07, 2014
NASOPORE-FD
K141423
Polyganics B.V.,
Ear, Nose, Throat · 69d
Cleared Jun 16, 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992
ArthroCare Corporation
Ear, Nose, Throat · 60d
Cleared Jan 29, 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721
Spiway, LLC
Ear, Nose, Throat · 152d
Cleared May 29, 2013
MEDIENT MIDDLE TURBINATE IMPLANT
K130354
Entrigue Surgical, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 27, 2013
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494
Hemostasis, LLC
Ear, Nose, Throat · 223d
Cleared Apr 25, 2012
NASAL/EPISTAXIS PACK
K113585
Cogent Therapeutics, LLC
Ear, Nose, Throat · 142d
Cleared Nov 17, 2009
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401
Sinexus, Inc.
Ear, Nose, Throat · 103d
Cleared Nov 18, 2008
SYNTHEMED DEVICE
K082276
Synthemed, Inc.
Ear, Nose, Throat · 99d
Cleared Feb 27, 2008
QUIKCLOT NOSEBLEED
K080247
Z-Medica Corporation
General & Plastic Surgery · 27d
Cleared Mar 15, 2007
ADVACOAT SINUS GEL AND STENT
K070496
Carbylan Biosurgery
Ear, Nose, Throat · 23d
Cleared Dec 04, 2006
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308
Carbylan Biosurgery
Ear, Nose, Throat · 32d
Cleared Nov 21, 2005
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
K052099
Polyganics B.V.,
Ear, Nose, Throat · 110d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381
Medtronic Xomed, Inc.
Ear, Nose, Throat · 108d

About Product Code LYA - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code LYA since 1983, with 46 receiving FDA clearance (average review time: 96 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - LYA Product Code

Recent submissions under LYA have taken an average of 227 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.

LYA devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →