NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable Class II
FDA product code NHB covers "Polymer, Ear, Nose And Throat, Synthetic, Absorbable", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHB
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251790 | spirair | SeptAlign | January 16, 2026 |
| K233569 | spirair | SeptAlign | March 22, 2024 |
| K223167 | spirair | Spirair Nasal Septal Strap | August 17, 2023 |
| K210411 | hemostasis | PosiSep EAR Fragmentable Ear Dressing | May 5, 2022 |
| K192661 | entellus medical, inc. (aka stryker ent) | LATERA Absorbable Nasal Implant System | November 10, 2019 |
| K183015 | 3-d matrix | PuraSinus | April 12, 2019 |
| K161191 | spirox | Latera Absorbable Nasal Implant | June 23, 2016 |
| K152958 | spirox | INEX Absorbable Nasal Implant | December 4, 2015 |
| K132920 | spirox | SPIROX INEX DEVICE | June 10, 2014 |
| K122434 | medtronic xomed | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | October 31, 2012 |
| K092590 | ethicon | PDS PLATES | February 17, 2010 |
| K070715 | polyganics b.v | NASOPORE EAR | May 7, 2007 |
| K070886 | medtronic | MEROGEL INJECTABLE BIORESORBABLE STENT | April 26, 2007 |
| K012769 | macropore biosurgery | MACROPORE ENT RECONSTRUCTION FILM | October 25, 2001 |
| K012409 | walter lorenz surgical | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | October 18, 2001 |