Polymer, Ear, Nose And Throat, Synthetic, Absorbable
The Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB) is a synthetic absorbable polymeric biomaterial used in ear, nose, and throat surgical procedures, where it provides temporary structural support or space maintenance before being absorbed by the body, as described in its definition. It is classified as an FDA Class 2 device within the Ear, Nose, and Throat specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation and is not flagged as life-sustaining.
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Basic Information
- Product Code
- NHB
- Device Class
- FDA class 2
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251790 | SeptAlign | Jan 16, 2026 | Substantially Equivalent | Spirair, Inc. |
| K233569 | SeptAlign | Mar 22, 2024 | Substantially Equivalent | Spirair, Inc. |
| K223167 | Spirair Nasal Septal Strap | Aug 17, 2023 | Substantially Equivalent | Spirair, Inc. |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | May 05, 2022 | Substantially Equivalent | Hemostasis, LLC |
| K192661 | LATERA Absorbable Nasal Implant System | Nov 10, 2019 | Substantially Equivalent | Entellus Medical, Inc. (Aka Stryker Ent) |
| K183015 | PuraSinus | Apr 12, 2019 | Substantially Equivalent | 3-D Matrix, Inc. |
| K161191 | Latera Absorbable Nasal Implant | Jun 23, 2016 | Substantially Equivalent | Spirox, Inc. |
| K152958 | INEX Absorbable Nasal Implant | Dec 04, 2015 | Substantially Equivalent | Spirox, Inc. |
| K132920 | SPIROX INEX DEVICE | Jun 10, 2014 | Substantially Equivalent | Spirox, Inc. |
| K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | Oct 31, 2012 | Substantially Equivalent | Medtronic Xomed |
| K092590 | PDS PLATES | Feb 17, 2010 | Substantially Equivalent | ETHICON, Inc. |
| K070715 | NASOPORE EAR | May 07, 2007 | Substantially Equivalent | Polyganics B.V., |
| K070886 | MEROGEL INJECTABLE BIORESORBABLE STENT | Apr 26, 2007 | Substantially Equivalent | Medtronic, Inc. |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Oct 25, 2001 | Substantially Equivalent | Macropore Biosurgery, Inc. |
| K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | Oct 18, 2001 | Substantially Equivalent | Walter Lorenz Surgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.