NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | NHB |
|---|---|
| Device Name | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
Ear, nose, and throat 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 used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251790 | SeptAlign | Spirair, Inc. | Jan 16, 2026 | SESE |
| K233569 | SeptAlign | Spirair, Inc. | Mar 22, 2024 | SESE |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | Aug 17, 2023 | SESE |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | May 5, 2022 | SESE |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | Nov 10, 2019 | SESE |
| K183015 | PuraSinus | 3-D Matrix, Inc. | Apr 12, 2019 | SESE |
| K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | Jun 23, 2016 | SESE |
| K152958 | INEX Absorbable Nasal Implant | Spirox, Inc. | Dec 4, 2015 | SESE |
| K132920 | SPIROX INEX DEVICE | Spirox, Inc. | Jun 10, 2014 | SESE |
| K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | Medtronic Xomed | Oct 31, 2012 | SESE |
| K092590 | PDS PLATES | ETHICON, Inc. | Feb 17, 2010 | SESE |
| K070715 | NASOPORE EAR | Polyganics B.V., | May 7, 2007 | SESE |
| K070886 | MEROGEL INJECTABLE BIORESORBABLE STENT | Medtronic, Inc. | Apr 26, 2007 | SESE |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Macropore Biosurgery, Inc. | Oct 25, 2001 | SESE |
| K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | Walter Lorenz Surgical, Inc. | Oct 18, 2001 | SESE |
Top Applicants
- Spirair, Inc. — 3 clearances
- Spirox, Inc. — 3 clearances
- 3-D Matrix, Inc. — 1 clearance
- ETHICON, Inc. — 1 clearance
- Entellus Medical, Inc. (Aka Stryker Ent) — 1 clearance
