21 CFR § 874.3820 Ear, Nose, and Throat Devices

§ 874.3820 Endolymphatic shunt.

Current through Sep 8, 2026 · Read all of Part 874

(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.

← § 874.3760 Sacculotomy tack (Cody tack)§ 874.3850 Endolymphatic shunt tube with valve. →