NHB

16 FDA 510(k) clearances · Product code

FDA profile

Official device name

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Device class

Class II (moderate risk)

Regulation

21 CFR 874.3620

Medical specialty

Ear, Nose, Throat

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.

Adverse events (MAUDE)

2017: 22 · 2018: 17 · 2019: 27 · 2021: 16 · 2024: 19 · 2025: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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