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§ 874.3820 Endolymphatic shunt.

21 CFR 874.3820

Citation21 CFR 874.3820
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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.