LYAClass I

Splint, Intranasal Septal

21 CFR 874.4780 / Ear, Nose, Throat

LYA is the FDA product code for Splint, Intranasal Septal, a class I device type, regulated under 21 CFR 874.4780. As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2025-07-11, and 2 recalls.

Classification record

Product code: LYA
Device name: Splint, Intranasal Septal
Regulation: 21 CFR 874.4780
Device class: Class I
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 46
Ingested recalls: 2

Clearances, product code LYA

By decision year

46 clearances under product code LYA with a decision year between 1983 and 2025, 2014 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code LYA by decision year
Year	Clearances
1983	1
1990	2
1992	2
1993	2
1994	2
1995	4
1997	4
1998	2
2001	3
2004	1
2005	1
2006	1
2007	1
2008	2
2009	1
2012	1
2013	2
2014	5
2016	1
2017	2
2018	2
2020	1
2021	1
2023	1
2025	1

Applicants with the most clearances

Product code LYA

Applicants holding the most 510(k) clearances under product code LYA
Applicant	Clearances
Boston Medical Products, Inc.	4
SPIWay, LLC	4
Polyganics B.V.	3
Smith & Nephew Richards, Inc.	3
Carbylan Biosurgery	2
Invotec International, Inc.	2
Medtronic Xomed, Inc.	2
Merocel Corp.	2
ArthroCare Corporation	1
Biomed ENT, Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 87 companies shown, in name order