Product code LYA
- Device name
- Splint, Intranasal Septal
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4780
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243655 | TurbAlign | Spirair, Inc. | 2025-07-11 |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023-03-22 |
| K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | 2021-10-27 |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | 2020-12-08 |
| K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018-11-30 |
| K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | 2018-02-16 |
| K170913 | Composite Removable Sinus Stent System | Sts Medical | 2017-12-15 |
| K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017-10-17 |
| K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | 2016-01-28 |
| K141816 | HEMOPORE | Polyganics B.V., | 2014-10-23 |
| K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | Medtronic, Inc. | 2014-10-06 |
| K141423 | NASOPORE-FD | Polyganics B.V., | 2014-08-07 |
| K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | ArthroCare Corporation | 2014-06-16 |
| K132721 | SPIWAY ENDONASAL ACCESS GUIDE | Spiway, LLC | 2014-01-29 |
| K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) | Entrigue Surgical, Inc. | 2013-05-29 |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | Hemostasis, LLC | 2013-03-27 |
| K113585 | NASAL/EPISTAXIS PACK | Cogent Therapeutics, LLC | 2012-04-25 |
| K092401 | SINEXUS SINUS STENT GEN 2, MODEL 1999-25 | Sinexus, Inc. | 2009-11-17 |
| K082276 | SYNTHEMED DEVICE | Synthemed, Inc. | 2008-11-18 |
| K080247 | QUIKCLOT NOSEBLEED | Z-Medica Corporation | 2008-02-27 |
| K070496 | ADVACOAT SINUS GEL AND STENT | Carbylan Biosurgery | 2007-03-15 |
| K063308 | ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 | Carbylan Biosurgery | 2006-12-04 |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | Polyganics B.V., | 2005-11-21 |
| K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT | Medtronic Xomed, Inc. | 2004-09-10 |
| K012532 | SEPRAGEL SINUS | Genzyme Corp. | 2001-10-30 |
| K011544 | HADGEL, 4 GRAM/SYRINGE | Seikagaku Corp. | 2001-08-15 |
| K002131 | LACTOSORB ETHMOID STENT | Walter Lorenz Surgical, Inc. | 2001-04-13 |
| K981374 | POREX NOSTRIL RETAINERS | Porex Surgical, Inc. | 1998-07-02 |
| K980221 | SILIMED NASAL RETAINER | Silimed, LLC | 1998-04-02 |
| K972096 | BIVALVE NASAL SPLINT | Boston Medical Products, Inc. | 1997-07-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850056665305 | ORCA Foam | Orca Products, LLC | 2026-05-07 |
| 10860008863338 | NasalCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863321 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863314 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863307 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008294347 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 14063107102346 | Custom Nasal Splint | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102339 | Custom Nasal Splint | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102322 | Bivalve Nasal Splint, Large | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102315 | Bivalve Nasal Splint, Large | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102308 | Bivalve Nasal Splint, Standard | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102292 | Bivalve Nasal Splint, Standard | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102285 | Intranasl Splint INS | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102278 | Doyle Open-Lumen Splint | Boston Medical Products, Inc. | 2022-09-29 |
| 14063107102261 | Nasal Airway Splint | Boston Medical Products, Inc. | 2022-09-29 |
| 10860008294309 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 10860003109998 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 10860003109981 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 10860003109974 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 07613327500486 | Hemopore | STRYKER CORPORATION | 2020-01-08 |
| 07613327500479 | Nasopore | STRYKER CORPORATION | 2020-01-08 |
| 07613327500387 | Nasopore | STRYKER CORPORATION | 2020-01-08 |
| 07613154340798 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613327117233 | Hemopore | STRYKER CORPORATION | 2018-09-24 |
| 07613327117226 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613154340842 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613154340835 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613154340828 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613154340811 | Nasopore | STRYKER CORPORATION | 2018-09-24 |
| 07613154340804 | Nasopore | STRYKER CORPORATION | 2018-09-24 |