LYA · Splint, Intranasal Septal
Ear, Nose, Throat · 21 CFR 874.4780 · Class 1
Overview
| Product Code | LYA |
|---|---|
| Device Name | Splint, Intranasal Septal |
| Regulation | 21 CFR 874.4780 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Cleared Devices (46)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243655 | TurbAlign | Spirair, Inc. | Jul 11, 2025 | SESE |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | Mar 22, 2023 | SESE |
| K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | Oct 27, 2021 | SESE |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | Dec 8, 2020 | SESE |
| K181696 | ChitoZolve | Gyrus Acmi, Inc. | Nov 30, 2018 | SESE |
| K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | Feb 16, 2018 | SESE |
| K170913 | Composite Removable Sinus Stent System | Sts Medical | Dec 15, 2017 | SESE |
| K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | Oct 17, 2017 | SESE |
| K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | Jan 28, 2016 | SESE |
| K141816 | HEMOPORE | Polyganics B.V., | Oct 23, 2014 | SESE |
| K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | Medtronic, Inc. | Oct 6, 2014 | SESE |
| K141423 | NASOPORE-FD | Polyganics B.V., | Aug 7, 2014 | SESE |
| K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | ArthroCare Corporation | Jun 16, 2014 | SESE |
| K132721 | SPIWAY ENDONASAL ACCESS GUIDE | Spiway, LLC | Jan 29, 2014 | SESE |
| K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) | Entrigue Surgical, Inc. | May 29, 2013 | SESE |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | Hemostasis, LLC | Mar 27, 2013 | SESE |
| K113585 | NASAL/EPISTAXIS PACK | Cogent Therapeutics, LLC | Apr 25, 2012 | SESE |
| K092401 | SINEXUS SINUS STENT GEN 2, MODEL 1999-25 | Sinexus, Inc. | Nov 17, 2009 | SESE |
| K082276 | SYNTHEMED DEVICE | Synthemed, Inc. | Nov 18, 2008 | SESE |
| K080247 | QUIKCLOT NOSEBLEED | Z-Medica Corporation | Feb 27, 2008 | SESE |
| K070496 | ADVACOAT SINUS GEL AND STENT | Carbylan Biosurgery | Mar 15, 2007 | SESE |
| K063308 | ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 | Carbylan Biosurgery | Dec 4, 2006 | SESE |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | Polyganics B.V., | Nov 21, 2005 | SESE |
| K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT | Medtronic Xomed, Inc. | Sep 10, 2004 | SESE |
| K012532 | SEPRAGEL SINUS | Genzyme Corp. | Oct 30, 2001 | SESE |
| K011544 | HADGEL, 4 GRAM/SYRINGE | Seikagaku Corp. | Aug 15, 2001 | SESE |
| K002131 | LACTOSORB ETHMOID STENT | Walter Lorenz Surgical, Inc. | Apr 13, 2001 | SESE |
| K981374 | POREX NOSTRIL RETAINERS | Porex Surgical, Inc. | Jul 2, 1998 | SESE |
| K980221 | SILIMED NASAL RETAINER | Silimed, LLC | Apr 2, 1998 | SESE |
| K972096 | BIVALVE NASAL SPLINT | Boston Medical Products, Inc. | Jul 15, 1997 | SESE |
| K972092 | NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | Jul 8, 1997 | SESE |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | Boston Medical Products, Inc. | Jul 7, 1997 | SESE |
| K972082 | CUSTOM NASAL SPLINT | Boston Medical Products, Inc. | Jul 3, 1997 | SESE |
| K954449 | ENT PACKINGS, WICKS, WIPES, AND SPONGES | Oasis | Nov 14, 1995 | SESE |
| K952226 | C-FLEX SEPTAL SPLINTS | Trebay Medical Corp. | Aug 11, 1995 | SESE |
| K952207 | NASAL SEPTAL SPLINT | Smith & Nephew Richards, Inc. | Jun 7, 1995 | SESE |
| K945555 | NASAL SPLINT | Ultracell Medical Technologies, Inc. | Jan 19, 1995 | SESE |
| K935053 | BIVONA NASAL TURBINATE STENT | Bivona Medical Technologies | Jul 1, 1994 | SESE |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | Merocel Corp. | Mar 4, 1994 | SESE |
| K933152 | MEROCEL MEROSPLINT | Merocel Corp. | Aug 17, 1993 | SESE |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | Westmed Intl. | Jan 15, 1993 | SESE |
| K921202 | TURBINATE NASAL SPLINT | Smith & Nephew Richards, Inc. | Jul 23, 1992 | SESE |
| K921195 | NASAL SEPTAL SPLINT | Smith & Nephew Richards, Inc. | Jul 23, 1992 | SESE |
| K901307 | PASSAGE AIRWAY SPLINT | Invotec International, Inc. | Jun 14, 1990 | SESE |
| K901306 | INVOTEC BI-VALVE SPLINT | Invotec International, Inc. | Jun 14, 1990 | SESE |
| K830263 | FLORET NASAL TAMPON | Ritmed, Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Spiway, LLC — 4 clearances
- Boston Medical Products, Inc. — 4 clearances
- Smith & Nephew Richards, Inc. — 3 clearances
- Polyganics B.V., — 3 clearances
- Merocel Corp. — 2 clearances
