FDA 510(k) Applications for Medical Device Product Code "LYA"
(Splint, Intranasal Septal)

FDA 510(k) Number Applicant Device Name Decision Date
K140992 ARTHROCARE CORPORATION ARTHROCARE NASASTENT CMC NASAL DRESSING 06/16/2014
K230142 BioMed ENT, Inc. Epi-Stop Nasal Gel/epistaxis pack 03/22/2023
K972096 BOSTON MEDICAL PRODUCTS, INC. BIVALVE NASAL SPLINT 07/15/1997
K972082 BOSTON MEDICAL PRODUCTS, INC. CUSTOM NASAL SPLINT 07/03/1997
K972151 BOSTON MEDICAL PRODUCTS, INC. DOYLE COMBO NASAL AIRWAY SPLINT 07/07/1997
K972092 BOSTON MEDICAL PRODUCTS, INC. NASAL AIRWAY SPLINT 07/08/1997
K070496 CARBYLAN BIOSURGERY ADVACOAT SINUS GEL AND STENT 03/15/2007
K063308 CARBYLAN BIOSURGERY ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 12/04/2006
K172179 Chitogel Ltd Chitogel Endoscopic Sinus Surgery Kit 10/17/2017
K113585 COGENT THERAPEUTICS, LLC NASAL/EPISTAXIS PACK 04/25/2012
K130354 ENTRIGUE SURGICAL, INC. MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) 05/29/2013
K012532 GENZYME CORP. SEPRAGEL SINUS 10/30/2001
K181696 Gyrus ACMI, Inc ChitoZolve 11/30/2018
K122494 HEMOSTASIS, LLC POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT 03/27/2013
K141704 MEDTRONIC INC. NOVASHIELD INJECTABLE NASAL PACKING AND STENT 10/06/2014
K202623 Medtronic Xomed Novapak Nasal Sinus Packing and Stent 12/08/2020
K041381 MEDTRONIC XOMED, INC. MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT 09/10/2004
K141816 Polyganics BV HEMOPORE 10/23/2014
K052099 Polyganics BV NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ 11/21/2005
K141423 Polyganics BV NASOPORE-FD 08/07/2014
K981374 POREX SURGICAL, INC. POREX NOSTRIL RETAINERS 07/02/1998
K011544 SEIKAGAKU CORP. HADGEL, 4 GRAM/SYRINGE 08/15/2001
K980221 SILIMED, LLC. SILIMED NASAL RETAINER 04/02/1998
K092401 SINEXUS, INC. SINEXUS SINUS STENT GEN 2, MODEL 1999-25 11/17/2009
K132721 SPIWAY LLC SPIWAY ENDONASAL ACCESS GUIDE 01/29/2014
K153686 SPIWAY LLC SPIWay Endonasal Access Guide 01/28/2016
K180141 SPIWay, LLC SPIWay Endonasal Access Guide 02/16/2018
K213153 SPIWay, LLC SPIWay Endonasal Access Guide 10/27/2021
K170913 STS Medical Composite Removable Sinus Stent System 12/15/2017
K082276 SYNTHEMED, INC. SYNTHEMED DEVICE 11/18/2008
K002131 WALTER LORENZ SURGICAL, INC. LACTOSORB ETHMOID STENT 04/13/2001
K080247 Z-MEDICA CORPORATION QUIKCLOT NOSEBLEED 02/27/2008


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