Product Code: LYA FDA class 1 21 CFR 874.4780

Splint, Intranasal Septal

Ear, Nose, Throat

The Intranasal Septal Splint (product code LYA) is a device inserted into the nasal passages following nasal septal surgery (septoplasty) or nasal fracture repair to support the septum during healing, maintain nasal airway patency, and prevent adhesion formation. Regulated under 21 CFR 874.4780 and classified as a Class 1 device subject only to general controls, it falls under the Ear, Nose, and Throat specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.

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510(k)s

FEI Numbers

106

Registration Numbers

106

Unique Applicants

Years Active

Basic Information

Product Code: LYA
Device Class: FDA class 1
Regulation Number: 874.4780
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243655	TurbAlign	Jul 11, 2025	Substantially Equivalent	Spirair, Inc.
K230142	Epi-Stop Nasal Gel/epistaxis pack	Mar 22, 2023	Substantially Equivalent	Biomed Ent, Inc.
K213153	SPIWay Endonasal Access Guide	Oct 27, 2021	Substantially Equivalent	Spiway, LLC
K202623	Novapak Nasal Sinus Packing and Stent	Dec 08, 2020	Substantially Equivalent	Medtronic Xomed
K181696	ChitoZolve	Nov 30, 2018	Substantially Equivalent	Gyrus Acmi, Inc.
K180141	SPIWay Endonasal Access Guide	Feb 16, 2018	Substantially Equivalent	Spiway, LLC
K170913	Composite Removable Sinus Stent System	Dec 15, 2017	Substantially Equivalent	Sts Medical
K172179	Chitogel Endoscopic Sinus Surgery Kit	Oct 17, 2017	Substantially Equivalent	Chitogel, Ltd.
K153686	SPIWay Endonasal Access Guide	Jan 28, 2016	Substantially Equivalent	Spiway, LLC
K141816	HEMOPORE	Oct 23, 2014	Substantially Equivalent	Polyganics B.V.,
K141704	NOVASHIELD INJECTABLE NASAL PACKING AND STENT	Oct 06, 2014	Substantially Equivalent	Medtronic, Inc.
K141423	NASOPORE-FD	Aug 07, 2014	Substantially Equivalent	Polyganics B.V.,
K140992	ARTHROCARE NASASTENT CMC NASAL DRESSING	Jun 16, 2014	Substantially Equivalent	ArthroCare Corporation
K132721	SPIWAY ENDONASAL ACCESS GUIDE	Jan 29, 2014	Substantially Equivalent	Spiway, LLC
K130354	MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)	May 29, 2013	Substantially Equivalent	Entrigue Surgical, Inc.
K122494	POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT	Mar 27, 2013	Substantially Equivalent	Hemostasis, LLC
K113585	NASAL/EPISTAXIS PACK	Apr 25, 2012	Substantially Equivalent	Cogent Therapeutics, LLC
K092401	SINEXUS SINUS STENT GEN 2, MODEL 1999-25	Nov 17, 2009	Substantially Equivalent	Sinexus, Inc.
K082276	SYNTHEMED DEVICE	Nov 18, 2008	Substantially Equivalent	Synthemed, Inc.
K080247	QUIKCLOT NOSEBLEED	Feb 27, 2008	Substantially Equivalent	Z-Medica Corporation
K070496	ADVACOAT SINUS GEL AND STENT	Mar 15, 2007	Substantially Equivalent	Carbylan Biosurgery
K063308	ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200	Dec 04, 2006	Substantially Equivalent	Carbylan Biosurgery
K052099	NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ	Nov 21, 2005	Substantially Equivalent	Polyganics B.V.,
K041381	MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT	Sep 10, 2004	Substantially Equivalent	Medtronic Xomed, Inc.
K012532	SEPRAGEL SINUS	Oct 30, 2001	Substantially Equivalent	Genzyme Corp.
K011544	HADGEL, 4 GRAM/SYRINGE	Aug 15, 2001	Substantially Equivalent	Seikagaku Corp.
K002131	LACTOSORB ETHMOID STENT	Apr 13, 2001	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K981374	POREX NOSTRIL RETAINERS	Jul 02, 1998	Substantially Equivalent	Porex Surgical, Inc.
K980221	SILIMED NASAL RETAINER	Apr 02, 1998	Substantially Equivalent	Silimed, LLC
K972096	BIVALVE NASAL SPLINT	Jul 15, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972092	NASAL AIRWAY SPLINT	Jul 08, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972151	DOYLE COMBO NASAL AIRWAY SPLINT	Jul 07, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K972082	CUSTOM NASAL SPLINT	Jul 03, 1997	Substantially Equivalent	Boston Medical Products, Inc.
K954449	ENT PACKINGS, WICKS, WIPES, AND SPONGES	Nov 14, 1995	Substantially Equivalent	Oasis
K952226	C-FLEX SEPTAL SPLINTS	Aug 11, 1995	Substantially Equivalent	Trebay Medical Corp.
K952207	NASAL SEPTAL SPLINT	Jun 07, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K945555	NASAL SPLINT	Jan 19, 1995	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K935053	BIVONA NASAL TURBINATE STENT	Jul 01, 1994	Substantially Equivalent	Bivona Medical Technologies
K935658	MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT	Mar 04, 1994	Substantially Equivalent	Merocel Corp.
K933152	MEROCEL MEROSPLINT	Aug 17, 1993	Substantially Equivalent	Merocel Corp.
K925173	BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT	Jan 15, 1993	Substantially Equivalent	Westmed Intl.
K921202	TURBINATE NASAL SPLINT	Jul 23, 1992	Substantially Equivalent	Smith & Nephew Richards, Inc.
K921195	NASAL SEPTAL SPLINT	Jul 23, 1992	Substantially Equivalent	Smith & Nephew Richards, Inc.
K901307	PASSAGE AIRWAY SPLINT	Jun 14, 1990	Substantially Equivalent	Invotec International, Inc.
K901306	INVOTEC BI-VALVE SPLINT	Jun 14, 1990	Substantially Equivalent	Invotec International, Inc.
K830263	FLORET NASAL TAMPON	Mar 24, 1983	Substantially Equivalent	Ritmed, Inc.