Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 874.3820 - Endolymphatic shunt.

(a) 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.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
cite as: 21 CFR 874.3820