Panels › Ear, Nose, Throat › Product code LYA · Class 1
Splint, Intranasal Septal
Regulation 874.4780
0510(k)s in 12 months (46 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LYA
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Medical Products, Inc. | 4 | 0 |
| Spiway, LLC | 4 | 0 |
| Polyganics B.V., | 3 | 0 |
| Smith & Nephew Richards, Inc. | 3 | 0 |
| Carbylan Biosurgery | 2 | 0 |
| Invotec International, Inc. | 2 | 0 |
| Medtronic Xomed | 2 | 0 |
| Merocel Corp. | 2 | 0 |
| Porex Surgical, Inc. | 1 | 1 |
| ArthroCare Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2025 | K243655 | TurbAlign Spirair, Inc. | LYA |
| Mar 22, 2023 | K230142 | Epi-Stop Nasal Gel/epistaxis pack Biomed Ent, Inc. | LYA |
| Oct 27, 2021 | K213153 | SPIWay Endonasal Access Guide Spiway, LLC | LYA |
| Dec 8, 2020 | K202623 | Novapak Nasal Sinus Packing and Stent Medtronic Xomed | LYA |
| Nov 30, 2018 | K181696 | ChitoZolve Gyrus Acmi, Inc. | LYA |
| Feb 16, 2018 | K180141 | SPIWay Endonasal Access Guide Spiway, LLC | LYA |
| Dec 15, 2017 | K170913 | Composite Removable Sinus Stent System Sts Medical, IL | LYA |
| Oct 17, 2017 | K172179 | Chitogel Endoscopic Sinus Surgery Kit Chitogel, Ltd., NZ | LYA |
| Jan 28, 2016 | K153686 | SPIWay Endonasal Access Guide Spiway, LLC | LYA |
| Oct 23, 2014 | K141816 | HEMOPORE Polyganics B.V.,, NL | LYA |
| Oct 6, 2014 | K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT Medtronic, Inc. | LYA |
| Aug 7, 2014 | K141423 | NASOPORE-FD Polyganics B.V.,, NL | LYA |
| Jun 16, 2014 | K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING ArthroCare Corporation | LYA |
| Jan 29, 2014 | K132721 | SPIWAY ENDONASAL ACCESS GUIDE Spiway, LLC | LYA |
| May 29, 2013 | K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) Entrigue Surgical, Inc. | LYA |
| Mar 27, 2013 | K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT Hemostasis, LLC | LYA |
| Apr 25, 2012 | K113585 | NASAL/EPISTAXIS PACK Cogent Therapeutics, LLC | LYA |
| Nov 17, 2009 | K092401 | SINEXUS SINUS STENT GEN 2, MODEL 1999-25 Sinexus, Inc. | LYA |
| Nov 18, 2008 | K082276 | SYNTHEMED DEVICE Synthemed, Inc. | LYA |
| Feb 27, 2008 | K080247 | QUIKCLOT NOSEBLEED Z-Medica Corporation | LYA |
| Mar 15, 2007 | K070496 | ADVACOAT SINUS GEL AND STENT Carbylan Biosurgery | LYA |
| Dec 4, 2006 | K063308 | ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 Carbylan Biosurgery | LYA |
| Nov 21, 2005 | K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ Polyganics B.V.,, NL | LYA |
| Sep 10, 2004 | K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT Medtronic Xomed, Inc. | LYA |
| Oct 30, 2001 | K012532 | SEPRAGEL SINUS Genzyme Corp. | LYA |
| Aug 15, 2001 | K011544 | HADGEL, 4 GRAM/SYRINGE Seikagaku Corp. | LYA |
| Apr 13, 2001 | K002131 | LACTOSORB ETHMOID STENT Walter Lorenz Surgical, Inc. | LYA |
| Jul 2, 1998 | K981374 | POREX NOSTRIL RETAINERS Porex Surgical, Inc. | LYA |
| Apr 2, 1998 | K980221 | SILIMED NASAL RETAINER Silimed, LLC | LYA |
| Jul 15, 1997 | K972096 | BIVALVE NASAL SPLINT Boston Medical Products, Inc. | LYA |
| Jul 8, 1997 | K972092 | NASAL AIRWAY SPLINT Boston Medical Products, Inc. | LYA |
| Jul 7, 1997 | K972151 | DOYLE COMBO NASAL AIRWAY SPLINT Boston Medical Products, Inc. | LYA |
| Jul 3, 1997 | K972082 | CUSTOM NASAL SPLINT Boston Medical Products, Inc. | LYA |
| Nov 14, 1995 | K954449 | ENT PACKINGS, WICKS, WIPES, AND SPONGES Oasis | LYA |
| Aug 11, 1995 | K952226 | C-FLEX SEPTAL SPLINTS Trebay Medical Corp. | LYA |
| Jun 7, 1995 | K952207 | NASAL SEPTAL SPLINT Smith & Nephew Richards, Inc. | LYA |
| Jan 19, 1995 | K945555 | NASAL SPLINT Ultracell Medical Technologies, Inc. | LYA |
| Jul 1, 1994 | K935053 | BIVONA NASAL TURBINATE STENT Bivona Medical Technologies | LYA |
| Mar 4, 1994 | K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT Merocel Corp. | LYA |
| Aug 17, 1993 | K933152 | MEROCEL MEROSPLINT Merocel Corp. | LYA |
| Jan 15, 1993 | K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT Westmed Intl. | LYA |
| Jul 23, 1992 | K921202 | TURBINATE NASAL SPLINT Smith & Nephew Richards, Inc. | LYA |
| Jul 23, 1992 | K921195 | NASAL SEPTAL SPLINT Smith & Nephew Richards, Inc. | LYA |
| Jun 14, 1990 | K901307 | PASSAGE AIRWAY SPLINT Invotec International, Inc. | LYA |
| Jun 14, 1990 | K901306 | INVOTEC BI-VALVE SPLINT Invotec International, Inc. | LYA |
| Mar 24, 1983 | K830263 | FLORET NASAL TAMPON Ritmed, Inc. | LYA |
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