Atlas FDA

LYA

46 FDA 510(k) clearances · Product code

89 daysmedian time to decision
223 days90th percentile
46clearances measured

FDA profile

Official device name
Splint, Intranasal Septal
Device class
Class I (low risk)
Regulation
21 CFR 874.4780
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2015: 28 · 2016: 28 · 2017: 10 · 2018: 19 · 2021: 19 · 2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TurbAlign (K243655)Spirair, Inc.2025-07-11
Epi-Stop Nasal Gel/epistaxis pack (K230142)Biomed Ent, Inc.2023-03-22
SPIWay Endonasal Access Guide (K213153)Spiway, LLC2021-10-27
Novapak Nasal Sinus Packing and Stent (K202623)Medtronic Xomed2020-12-08
ChitoZolve (K181696)Gyrus Acmi, Inc.2018-11-30
SPIWay Endonasal Access Guide (K180141)Spiway, LLC2018-02-16
Composite Removable Sinus Stent System (K170913)Sts Medical2017-12-15
Chitogel Endoscopic Sinus Surgery Kit (K172179)Chitogel, Ltd.2017-10-17
SPIWay Endonasal Access Guide (K153686)Spiway, LLC2016-01-28
HEMOPORE (K141816)Polyganics B.V.,2014-10-23
NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704)Medtronic, Inc.2014-10-06
NASOPORE-FD (K141423)Polyganics B.V.,2014-08-07
ARTHROCARE NASASTENT CMC NASAL DRESSING (K140992)ArthroCare Corporation2014-06-16
SPIWAY ENDONASAL ACCESS GUIDE (K132721)Spiway, LLC2014-01-29
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (K130354)Entrigue Surgical, Inc.2013-05-29
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (K122494)Hemostasis, LLC2013-03-27
NASAL/EPISTAXIS PACK (K113585)Cogent Therapeutics, LLC2012-04-25
SINEXUS SINUS STENT GEN 2, MODEL 1999-25 (K092401)Sinexus, Inc.2009-11-17
SYNTHEMED DEVICE (K082276)Synthemed, Inc.2008-11-18
QUIKCLOT NOSEBLEED (K080247)Z-Medica Corporation2008-02-27
ADVACOAT SINUS GEL AND STENT (K070496)Carbylan Biosurgery2007-03-15
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 (K063308)Carbylan Biosurgery2006-12-04
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (K052099)Polyganics B.V.,2005-11-21
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381)Medtronic Xomed, Inc.2004-09-10
SEPRAGEL SINUS (K012532)Genzyme Corp.2001-10-30
HADGEL, 4 GRAM/SYRINGE (K011544)Seikagaku Corp.2001-08-15
LACTOSORB ETHMOID STENT (K002131)Walter Lorenz Surgical, Inc.2001-04-13
POREX NOSTRIL RETAINERS (K981374)Porex Surgical, Inc.1998-07-02
SILIMED NASAL RETAINER (K980221)Silimed, LLC1998-04-02
BIVALVE NASAL SPLINT (K972096)Boston Medical Products, Inc.1997-07-15
NASAL AIRWAY SPLINT (K972092)Boston Medical Products, Inc.1997-07-08
DOYLE COMBO NASAL AIRWAY SPLINT (K972151)Boston Medical Products, Inc.1997-07-07
CUSTOM NASAL SPLINT (K972082)Boston Medical Products, Inc.1997-07-03
ENT PACKINGS, WICKS, WIPES, AND SPONGES (K954449)Oasis1995-11-14
C-FLEX SEPTAL SPLINTS (K952226)Trebay Medical Corp.1995-08-11
NASAL SEPTAL SPLINT (K952207)Smith & Nephew Richards, Inc.1995-06-07
NASAL SPLINT (K945555)Ultracell Medical Technologies, Inc.1995-01-19
BIVONA NASAL TURBINATE STENT (K935053)Bivona Medical Technologies1994-07-01
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT (K935658)Merocel Corp.1994-03-04
MEROCEL MEROSPLINT (K933152)Merocel Corp.1993-08-17
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (K925173)Westmed Intl.1993-01-15
TURBINATE NASAL SPLINT (K921202)Smith & Nephew Richards, Inc.1992-07-23
NASAL SEPTAL SPLINT (K921195)Smith & Nephew Richards, Inc.1992-07-23
PASSAGE AIRWAY SPLINT (K901307)Invotec International, Inc.1990-06-14
INVOTEC BI-VALVE SPLINT (K901306)Invotec International, Inc.1990-06-14
FLORET NASAL TAMPON (K830263)Ritmed, Inc.1983-03-24

Track LYA automatically

Every clearance here is in the API, with alerts when new ones post.