21 CFR 874.3850
§ 874.3850 Endolymphatic shunt tube with valve.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3850, § 874.3850 Endolymphatic shunt tube with valve, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90228
- Permanent ID
ys:prov:90228@1- SHA-256
532b515cf6fded8f84217273d4cf5fc16c6d7e03724a8d9048b93ab00173dc83
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.