FDA Product Code
FDA Product Code NHB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3620
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026-07-30 | Traditional | PDF ↗ |
| K251790 | SeptAlign | Spirair, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K233569 | SeptAlign | Spirair, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023-08-17 | Traditional | PDF ↗ |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | 2022-05-05 | Traditional | PDF ↗ |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | 2019-11-10 | Special | PDF ↗ |
| K183015 | PuraSinus | 3-D Matrix, Inc. | 2019-04-12 | Traditional | PDF ↗ |
| K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | 2016-06-23 | Special | PDF ↗ |
| K152958 | INEX Absorbable Nasal Implant | Spirox, Inc. | 2015-12-04 | Traditional | PDF ↗ |
| K132920 | SPIROX INEX DEVICE | Spirox, Inc. | 2014-06-10 | Traditional | PDF ↗ |
| K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | Medtronic Xomed | 2012-10-31 | Special | PDF ↗ |
| K092590 | PDS PLATES | ETHICON, Inc. | 2010-02-17 | Traditional | PDF ↗ |
| K070715 | NASOPORE EAR | Polyganics B.V., | 2007-05-07 | Traditional | PDF ↗ |
| K070886 | MEROGEL INJECTABLE BIORESORBABLE STENT | Medtronic, Inc. | 2007-04-26 | Traditional | PDF ↗ |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Macropore Biosurgery, Inc. | 2001-10-25 | Traditional | PDF ↗ |
| K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | Walter Lorenz Surgical, Inc. | 2001-10-18 | Traditional | PDF ↗ |
Product code NHB · Class II · Ear, Nose, Throat. Data: openFDA.