NHBClass II

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

21 CFR 874.3620 / Ear, Nose, Throat

NHB is the FDA product code for Polymer, Ear, Nose And Throat, Synthetic, Absorbable, a class II device type, regulated under 21 CFR 874.3620. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 16 510(k) clearances under this code, the most recent dated 2026-07-30, and 15 recalls.

Classification record

Product code: NHB
Device name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
FDA 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.
Regulation: 21 CFR 874.3620
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 16
Ingested recalls: 15

Clearances, product code NHB

By decision year

16 clearances under product code NHB with a decision year between 2001 and 2026, 2001 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NHB by decision year
Year	Clearances
2001	2
2007	2
2010	1
2012	1
2014	1
2015	1
2016	1
2019	2
2022	1
2023	1
2024	1
2026	2

Applicants with the most clearances

Product code NHB

Applicants holding the most 510(k) clearances under product code NHB
Applicant	Clearances
Spirair, Inc	4
Spirox, Inc.	3
3-D Matrix, Inc.	1
Ethicon, Inc	1
Entellus Medical, Inc. (Aka Stryker Ent)	1
Hemostasis, LLC	1
Macropore Biosurgery, Inc.	1
Medtronic Xomed, Inc.	1
Medtronic, Inc.	1
Polyganics B.V.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order