ESZ · Class II · 21 CFR 874.3820

FDA Product Code ESZ: Tube, Shunt, Endolymphatic

Leading manufacturers include Treace Medical, Inc. and Exmoor Plastics , Ltd..

4
Total
4
Cleared
125d
Avg days
1984
Since

FDA 510(k) Cleared Tube, Shunt, Endolymphatic Devices (Product Code ESZ)

4 devices
1–4 of 4
Cleared Jan 27, 1998
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
K974224
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Sep 20, 1984
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
K834094
Treace Medical, Inc.
Ear, Nose, Throat · 297d

About Product Code ESZ - Regulatory Context