FDA Product Code
FDA Product Code LYA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4780
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243655 | TurbAlign | Spirair, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023-03-22 | Traditional | PDF ↗ |
| K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | 2021-10-27 | Special | PDF ↗ |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | 2020-12-08 | Traditional | PDF ↗ |
| K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018-11-30 | Traditional | PDF ↗ |
| K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | 2018-02-16 | Special | PDF ↗ |
| K170913 | Composite Removable Sinus Stent System | Sts Medical | 2017-12-15 | Traditional | PDF ↗ |
| K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017-10-17 | Traditional | PDF ↗ |
| K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | 2016-01-28 | Special | PDF ↗ |
| K141816 | HEMOPORE | Polyganics B.V., | 2014-10-23 | Traditional | PDF ↗ |
| K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | Medtronic, Inc. | 2014-10-06 | Traditional | PDF ↗ |
| K141423 | NASOPORE-FD | Polyganics B.V., | 2014-08-07 | Special | PDF ↗ |
| K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | ArthroCare Corporation | 2014-06-16 | Traditional | PDF ↗ |
| K132721 | SPIWAY ENDONASAL ACCESS GUIDE | Spiway, LLC | 2014-01-29 | Traditional | PDF ↗ |
| K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) | Entrigue Surgical, Inc. | 2013-05-29 | Traditional | PDF ↗ |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | Hemostasis, LLC | 2013-03-27 | Traditional | PDF ↗ |
| K113585 | NASAL/EPISTAXIS PACK | Cogent Therapeutics, LLC | 2012-04-25 | Traditional | PDF ↗ |
| K092401 | SINEXUS SINUS STENT GEN 2, MODEL 1999-25 | Sinexus, Inc. | 2009-11-17 | Traditional | PDF ↗ |
| K082276 | SYNTHEMED DEVICE | Synthemed, Inc. | 2008-11-18 | Traditional | PDF ↗ |
| K080247 | QUIKCLOT NOSEBLEED | Z-Medica Corporation | 2008-02-27 | Traditional | PDF ↗ |
| K070496 | ADVACOAT SINUS GEL AND STENT | Carbylan Biosurgery | 2007-03-15 | Special | PDF ↗ |
| K063308 | ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 | Carbylan Biosurgery | 2006-12-04 | Traditional | PDF ↗ |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | Polyganics B.V., | 2005-11-21 | Traditional | PDF ↗ |
| K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT | Medtronic Xomed, Inc. | 2004-09-10 | Traditional | PDF ↗ |
| K012532 | SEPRAGEL SINUS | Genzyme Corp. | 2001-10-30 | Traditional | PDF ↗ |
| K011544 | HADGEL, 4 GRAM/SYRINGE | Seikagaku Corp. | 2001-08-15 | Traditional | PDF ↗ |
| K002131 | LACTOSORB ETHMOID STENT | Walter Lorenz Surgical, Inc. | 2001-04-13 | Traditional | PDF ↗ |
| K981374 | POREX NOSTRIL RETAINERS | Porex Surgical, Inc. | 1998-07-02 | Traditional | PDF ↗ |
| K980221 | SILIMED NASAL RETAINER | Silimed, LLC | 1998-04-02 | Traditional | PDF ↗ |
| K972096 | BIVALVE NASAL SPLINT | Boston Medical Products, Inc. | 1997-07-15 | Traditional | PDF ↗ |
| K972092 | NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | 1997-07-08 | Traditional | PDF ↗ |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | 1997-07-07 | Traditional | PDF ↗ |
| K972082 | CUSTOM NASAL SPLINT | Boston Medical Products, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K954449 | ENT PACKINGS, WICKS, WIPES, AND SPONGES | Oasis | 1995-11-14 | Traditional | PDF ↗ |
| K952226 | C-FLEX SEPTAL SPLINTS | Trebay Medical Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K952207 | NASAL SEPTAL SPLINT | Smith & Nephew Richards, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K945555 | NASAL SPLINT | Ultracell Medical Technologies, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K935053 | BIVONA NASAL TURBINATE STENT | Bivona Medical Technologies | 1994-07-01 | Traditional | PDF ↗ |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | Merocel Corp. | 1994-03-04 | Traditional | PDF ↗ |
| K933152 | MEROCEL MEROSPLINT | Merocel Corp. | 1993-08-17 | Traditional | PDF ↗ |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | Westmed Intl. | 1993-01-15 | Traditional | PDF ↗ |
| K921202 | TURBINATE NASAL SPLINT | Smith & Nephew Richards, Inc. | 1992-07-23 | Traditional | PDF ↗ |
| K921195 | NASAL SEPTAL SPLINT | Smith & Nephew Richards, Inc. | 1992-07-23 | Traditional | PDF ↗ |
| K901307 | PASSAGE AIRWAY SPLINT | Invotec International, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K901306 | INVOTEC BI-VALVE SPLINT | Invotec International, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K830263 | FLORET NASAL TAMPON | Ritmed, Inc. | 1983-03-24 | Traditional | PDF ↗ |
Product code LYA · Class I · Ear, Nose, Throat. Data: openFDA.