Splint, Intranasal Septal
FDA product code LYA · Class I (low risk) · 21 CFR 874.4780 · Ear, Nose, Throat
46510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Spiway, LLC 4
- Boston Medical Products, Inc. 4
- Smith & Nephew Richards, Inc. 3
- Polyganics B.V., 3
- Invotec International, Inc. 2
- Carbylan Biosurgery 2
- Medtronic Xomed, Inc. 2
- Merocel Corp. 2
- Trebay Medical Corp. 1
- Oasis 1
- Ultracell Medical Technologies, Inc. 1
- Silimed, LLC 1
- Porex Surgical, Inc. 1
- Walter Lorenz Surgical, Inc. 1
- Seikagaku Corp. 1
- Genzyme Corp. 1
- Bivona Medical Technologies 1
- Westmed Intl. 1
- Z-Medica, LLC 1
- Spirair, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243655 | TurbAlignLYA · Traditional | Spirair, Inc. | 07/11/2025SE |
| K230142 | Epi-Stop Nasal Gel/epistaxis packLYA · Traditional | Biomed Ent, Inc. | 03/22/2023SE |
| K213153 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 10/27/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | Medtronic Xomed | 12/08/2020SE |
| K181696 | ChitoZolveLYA · Traditional | Gyrus Acmi, Inc. | 11/30/2018SE |
| K180141 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 02/16/2018SE |
| K170913 | Composite Removable Sinus Stent SystemLYA · Traditional | Sts Medical | 12/15/2017SE |
| K172179 | Chitogel Endoscopic Sinus Surgery KitLYA · Traditional | Chitogel, Ltd. | 10/17/2017SE |
| K153686 | SPIWay Endonasal Access GuideLYA · Special | Spiway, LLC | 01/28/2016SE |
| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
| K141704 | Novashield Injectable Nasal Packing and StentLYA · Traditional | Medtronic, Inc. | 10/06/2014SE |
| K141423 | Nasopore-FdLYA · Special | Polyganics B.V., | 08/07/2014SE |
| K140992 | Arthrocare Nasastent CMC Nasal DressingLYA · Traditional | ArthroCare Corporation | 06/16/2014SE |
| K132721 | Spiway Endonasal Access GuideLYA · Traditional | Spiway, LLC | 01/29/2014SE |
| K130354 | Medient Middle Turbinate Implant; (Single PACK-1 Pair, Four PACK-4 Pair)LYA · Traditional | Entrigue Surgical, Inc. | 05/29/2013SE |
| K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal SplintLYA · Traditional | Hemostasis, LLC | 03/27/2013SE |
| K113585 | Nasal/Epistaxis PackLYA · Traditional | Cogent Therapeutics, LLC | 04/25/2012SE |
| K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25LYA · Traditional | Sinexus, Inc. | 11/17/2009SE |
| K082276 | Synthemed DeviceLYA · Traditional | Synthemed, Inc. | 11/18/2008SE |
| K080247 | Quikclot NosebleedLYA · Traditional | Z-Medica Corporation | 02/27/2008SE |
| K070496 | Advacoat Sinus Gel and StentLYA · Special | Carbylan Biosurgery | 03/15/2007SE |
| K063308 | Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200LYA · Traditional | Carbylan Biosurgery | 12/04/2006SE |
| K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZzLYA · Traditional | Polyganics B.V., | 11/21/2005SE |
| K041381 | Meropack Bioresorbable Nasal Packing and Sinus StentLYA · Traditional | Medtronic Xomed, Inc. | 09/10/2004SE |
| K012532 | Sepragel SinusLYA · Traditional | Genzyme Corp. | 10/30/2001SE |
| K011544 | Hadgel, 4 Gram/SyringeLYA · Traditional | Seikagaku Corp. | 08/15/2001SE |
| K002131 | Lactosorb Ethmoid StentLYA · Traditional | Walter Lorenz Surgical, Inc. | 04/13/2001SE |
| K981374 | Porex Nostril RetainersLYA · Traditional | Porex Surgical, Inc. | 07/02/1998SE |
| K980221 | Silimed Nasal RetainerLYA · Traditional | Silimed, LLC | 04/02/1998SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | Boston Medical Products, Inc. | 07/15/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | Boston Medical Products, Inc. | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | Boston Medical Products, Inc. | 07/07/1997SE |
| K972082 | Custom Nasal SplintLYA · Traditional | Boston Medical Products, Inc. | 07/03/1997SE |
| K954449 | ENT Packings, Wicks, Wipes, and SpongesLYA · Traditional | Oasis | 11/14/1995SE |
| K952226 | C-Flex Septal SplintsLYA · Traditional | Trebay Medical Corp. | 08/11/1995SE |
| K952207 | Nasal Septal SplintLYA · Traditional | Smith & Nephew Richards, Inc. | 06/07/1995SE |
| K945555 | Nasal SplintLYA · Traditional | Ultracell Medical Technologies, Inc. | 01/19/1995SE |
| K935053 | Bivona Nasal Turbinate StentLYA · Traditional | Bivona Medical Technologies | 07/01/1994SE |
| K935658 | Merocel(R) Turbinate Glove and Septal SplintLYA · Traditional | Merocel Corp. | 03/04/1994SE |
| K933152 | Merocel MerosplintLYA · Traditional | Merocel Corp. | 08/17/1993SE |
| K925173 | Boomerang Turbinate Glove and Septal SplintLYA · Traditional | Westmed Intl. | 01/15/1993SE |
| K921202 | Turbinate Nasal SplintLYA · Traditional | Smith & Nephew Richards, Inc. | 07/23/1992SE |
| K921195 | Nasal Septal SplintLYA · Traditional | Smith & Nephew Richards, Inc. | 07/23/1992SE |
| K901307 | Passage Airway SplintLYA · Traditional | Invotec International, Inc. | 06/14/1990SE |
| K901306 | Invotec Bi-Valve SplintLYA · Traditional | Invotec International, Inc. | 06/14/1990SE |
| K830263 | Floret Nasal TamponLYA · Traditional | Ritmed, Inc. | 03/24/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1768-2022 Class II | ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA…In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. | Gelita Medical GmbH | 07/27/2022Completed |