FDA product code NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NHB is the FDA product code for polymer, ear, nose and throat, synthetic, absorbable. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 16 510(k) submissions under NHB, 5 in the last five years, from 11 different applicants. The average 510(k) review took 147 days (median 110); 162 days on average over the last three years. FDA has posted 15 recalls for NHB devices, 14 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for NHB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 104 |
| 2022 | 1 | 448 |
| 2023 | 1 | 314 |
| 2024 | 1 | 137 |
| 2026 | 2 | 187 |
Compare with all 510(k) review times · Search every NHB clearance
Top NHB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spirair, Inc. | 4 | 2026-07-30 |
| Spirox, Inc. | 3 | 2016-06-23 |
| Hemostasis, LLC | 1 | 2022-05-05 |
| Entellus Medical, Inc. (Aka Stryker Ent) | 1 | 2019-11-10 |
| 3-D Matrix, Inc. | 1 | 2019-04-12 |
6 more applicants have NHB clearances. See the full list in Caduvo.
Most recent NHB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260620 | Spirair, Inc. | SeptAlign (SPLN001) | 2026-07-30 | 155 |
| K251790 | Spirair, Inc. | SeptAlign | 2026-01-16 | 219 |
| K233569 | Spirair, Inc. | SeptAlign | 2024-03-22 | 137 |
| K223167 | Spirair, Inc. | Spirair Nasal Septal Strap | 2023-08-17 | 314 |
| K210411 | Hemostasis, LLC | PosiSep EAR Fragmentable Ear Dressing | 2022-05-05 | 448 |
Recalls for NHB devices
15 product recalls in 2 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2025-02-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 14 |
Frequently asked questions
What is FDA product code NHB?
NHB is the FDA product code for polymer, ear, nose and throat, synthetic, absorbable. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is NHB?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHB?
Across 16 cleared submissions the average was 147 days from receipt to decision (median 110).
Which companies have the most NHB clearances?
Spirair, Inc. (4); Spirox, Inc. (3); Hemostasis, LLC (1); Entellus Medical, Inc. (Aka Stryker Ent) (1); 3-D Matrix, Inc. (1).
Have NHB devices been recalled?
Yes: 15 product recalls across 2 recall events; the most recent began 2025-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NHB
- Run a recall and safety report across every NHB manufacturer
- Watch product code NHB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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