21 CFR § 874.3850 - Endolymphatic shunt tube with valve.

---
identifier: "/us/cfr/t21/s874.3850"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3850 - Endolymphatic shunt tube with valve."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3850"
section_name: "Endolymphatic shunt tube with valve."
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"
---


# 874.3850 Endolymphatic shunt tube with valve.

(a) *Identification.* An endolymphatic shunt tube with valve is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease.

(b) *Classification.* Class II (special controls). The special control for this device is the FDA guidance document “Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA.”

[67 FR 20894, Apr. 29, 2002]