DeviceClearance

Product code NHB— Ear, Nose, Throat

SeptAlign

Classification name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Total cleared
16
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NHB under 21 CFR 874.3620, via openFDA

Market context for product code NHB

FDA has cleared 16 devices under product code NHB between 2001 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHB

Recent clearances under product code NHB

Data sourced from openFDA. This site is unofficial and independent of the FDA.