NHB · Class II · 21 CFR 874.3620

FDA Product Code NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

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.

Leading manufacturers include Spirair, Inc., Spirox, Inc. and Ethicon, Inc..

16
Total
16
Cleared
147d
Avg days
2001
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 187d recently vs 141d historically

FDA 510(k) Cleared Polymer, Ear, Nose And Throat, Synthetic, Absorbable Devices (Product Code NHB)

16 devices
1–16 of 16
Cleared Jul 30, 2026
SeptAlign (SPLN001)
K260620
Spirair, Inc.
Ear, Nose, Throat · 155d
Cleared Jan 16, 2026
SeptAlign
K251790
Spirair, Inc.
Ear, Nose, Throat · 219d
Cleared Mar 22, 2024
SeptAlign
K233569
Spirair, Inc.
Ear, Nose, Throat · 137d
Cleared Aug 17, 2023
Spirair Nasal Septal Strap
K223167
Spirair, Inc.
Ear, Nose, Throat · 314d
Cleared May 05, 2022
PosiSep EAR Fragmentable Ear Dressing
K210411
Hemostasis, LLC
Ear, Nose, Throat · 448d
Cleared Nov 10, 2019
LATERA Absorbable Nasal Implant System
K192661
Entellus Medical, Inc. (Aka Stryker Ent)
Ear, Nose, Throat · 46d
Cleared Apr 12, 2019
PuraSinus
K183015
3-D Matrix, Inc.
Ear, Nose, Throat · 163d
Cleared Jun 23, 2016
Latera Absorbable Nasal Implant
K161191
Spirox, Inc.
Ear, Nose, Throat · 57d
Cleared Dec 04, 2015
INEX Absorbable Nasal Implant
K152958
Spirox, Inc.
Ear, Nose, Throat · 58d
Cleared Jun 10, 2014
SPIROX INEX DEVICE
K132920
Spirox, Inc.
Ear, Nose, Throat · 266d
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Feb 17, 2010
PDS PLATES
K092590
Ethicon, Inc.
Ear, Nose, Throat · 177d
Cleared May 07, 2007
NASOPORE EAR
K070715
Polyganics B.V.,
Ear, Nose, Throat · 54d
Cleared Apr 26, 2007
MEROGEL INJECTABLE BIORESORBABLE STENT
K070886
Medtronic, Inc.
Ear, Nose, Throat · 27d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769
Macropore Biosurgery, Inc.
Ear, Nose, Throat · 69d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d

About Product Code NHB - Regulatory Context

510(k) Submission Activity

16 total 510(k) submissions under product code NHB since 2001, with 16 receiving FDA clearance (average review time: 147 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - NHB Product Code

Recent submissions under NHB have taken an average of 187 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.

NHB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →