KLZ · Tube, Shunt, Endolymphatic With Valve
Ear, Nose, Throat · 21 CFR 874.3850 · Class 2
Overview
| Product Code | KLZ |
|---|---|
| Device Name | Tube, Shunt, Endolymphatic With Valve |
| Regulation | 21 CFR 874.3850 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
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.”
Special Controls
*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.”
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972383 | EASY-JET DEVICE | A.Stein - Regulatory Affairs Consulting | Nov 23, 1999 | SESE |
Top Applicants
- A.Stein - Regulatory Affairs Consulting — 1 clearance
