21 CFR 874.3820 — Tube, Shunt, Endolymphatic
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3820
Identification
An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ESZ | Tube, Shunt, Endolymphatic | 2 | 4 | Implant |
