21 CFR § 874.3820 - Endolymphatic shunt.

---
identifier: "/us/cfr/t21/s874.3820"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3820 - Endolymphatic shunt."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3820"
section_name: "Endolymphatic shunt."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 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.