Splint, Intranasal Septal

FDA product code LYA · 41 cleared devices

Class 1 Ear, Nose, Throat

Regulation: 21 CFR 874.4780
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-03-24 – 2025-07-11

LYA 2025-07-11

TurbAlign

Applicant Spirair, Inc.

K number K243655

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LYA 2023-03-22

Epi-Stop Nasal Gel/epistaxis pack

Applicant Biomed Ent, Inc.

K number K230142

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LYA 2021-10-27

SPIWay Endonasal Access Guide

Applicant Spiway, LLC

K number K213153

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LYA 2020-12-08

Novapak Nasal Sinus Packing and Stent

Applicant Medtronic Xomed

K number K202623

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LYA 2018-11-30

ChitoZolve

Applicant Gyrus Acmi, Inc.

K number K181696

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LYA 2018-02-16

SPIWay Endonasal Access Guide

Applicant Spiway, LLC

K number K180141

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LYA 2017-12-15

Composite Removable Sinus Stent System

Applicant Sts Medical

K number K170913

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LYA 2017-10-17

Chitogel Endoscopic Sinus Surgery Kit

Applicant Chitogel, Ltd.

K number K172179

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LYA 2016-01-28

SPIWay Endonasal Access Guide

Applicant Spiway, LLC

K number K153686

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LYA 2013-05-29

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

Applicant Entrigue Surgical, Inc.

K number K130354

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LYA 2013-03-27

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT

Applicant Hemostasis, LLC

K number K122494

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LYA 2012-04-25

NASAL/EPISTAXIS PACK

Applicant Cogent Therapeutics, LLC

K number K113585

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LYA 2009-11-17

SINEXUS SINUS STENT GEN 2, MODEL 1999-25

Applicant Sinexus, Inc.

K number K092401

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LYA 2008-11-18

SYNTHEMED DEVICE

Applicant Synthemed, Inc.

K number K082276

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LYA 2008-02-27

QUIKCLOT NOSEBLEED

Applicant Z-Medica Corporation

K number K080247

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LYA 2007-03-15

ADVACOAT SINUS GEL AND STENT

Applicant Carbylan Biosurgery

K number K070496

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LYA 2006-12-04

ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200

Applicant Carbylan Biosurgery

K number K063308

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LYA 2005-11-21

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

Applicant Polyganics B.V.,

K number K052099

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LYA 2004-09-10

MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

Applicant Medtronic Xomed, Inc.

K number K041381

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LYA 2001-10-30

SEPRAGEL SINUS

Applicant Genzyme Corp.

K number K012532

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LYA 2001-08-15

HADGEL, 4 GRAM/SYRINGE

Applicant Seikagaku Corp.

K number K011544

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LYA 2001-04-13

LACTOSORB ETHMOID STENT

Applicant Walter Lorenz Surgical, Inc.

K number K002131

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LYA 1998-07-02

POREX NOSTRIL RETAINERS

Applicant Porex Surgical, Inc.

K number K981374

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LYA 1998-04-02

SILIMED NASAL RETAINER

Applicant Silimed, LLC

K number K980221

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LYA 1997-07-15

BIVALVE NASAL SPLINT

Applicant Boston Medical Products, Inc.

K number K972096

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LYA 1997-07-08

NASAL AIRWAY SPLINT

Applicant Boston Medical Products, Inc.

K number K972092

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LYA 1997-07-07

DOYLE COMBO NASAL AIRWAY SPLINT

Applicant Boston Medical Products, Inc.

K number K972151

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LYA 1997-07-03

CUSTOM NASAL SPLINT

Applicant Boston Medical Products, Inc.

K number K972082

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LYA 1995-11-14

ENT PACKINGS, WICKS, WIPES, AND SPONGES

Applicant Oasis

K number K954449

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LYA 1995-08-11

C-FLEX SEPTAL SPLINTS

Applicant Trebay Medical Corp.

K number K952226

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LYA 1995-06-07

NASAL SEPTAL SPLINT

Applicant Smith & Nephew Richards, Inc.

K number K952207

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LYA 1995-01-19

NASAL SPLINT

Applicant Ultracell Medical Technologies, Inc.

K number K945555

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LYA 1994-07-01

BIVONA NASAL TURBINATE STENT

Applicant Bivona Medical Technologies

K number K935053

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LYA 1994-03-04

MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT

Applicant Merocel Corp.

K number K935658

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LYA 1993-08-17

MEROCEL MEROSPLINT

Applicant Merocel Corp.

K number K933152

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LYA 1993-01-15

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT

Applicant Westmed Intl.

K number K925173

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LYA 1992-07-23

TURBINATE NASAL SPLINT

Applicant Smith & Nephew Richards, Inc.

K number K921202

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LYA 1992-07-23

NASAL SEPTAL SPLINT

Applicant Smith & Nephew Richards, Inc.

K number K921195

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LYA 1990-06-14

PASSAGE AIRWAY SPLINT

Applicant Invotec International, Inc.

K number K901307

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LYA 1990-06-14

INVOTEC BI-VALVE SPLINT

Applicant Invotec International, Inc.

K number K901306

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LYA 1983-03-24

FLORET NASAL TAMPON

Applicant Ritmed, Inc.

K number K830263

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