---
kind: "section"
citation: "21 C.F.R. § 874.3850"
title: "21"
number: "874.3850"
heading: "Endolymphatic shunt tube with valve."
url: "https://uscodex.org/cfr/21/874.3850"
---

# §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.”

## Notes

### Amendments

[67 FR 20894, Apr. 29, 2002]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[67 FR 20894, Apr. 29, 2002]