21 CFR 874.3850 — Tube, Shunt, Endolymphatic With Valve
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3850
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLZ | Tube, Shunt, Endolymphatic With Valve | 2 | 1 | Implant |
Special Controls
KLZ — Tube, Shunt, Endolymphatic With Valve
*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.”
eCFR
KLZ — Tube, Shunt, Endolymphatic With Valve
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.”
Ecfr Llm
