Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3850](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3850) → KLZ — Tube, Shunt, Endolymphatic With Valve

# KLZ · Tube, Shunt, Endolymphatic With Valve

_Ear, Nose, Throat · 21 CFR 874.3850 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLZ

## Overview

- **Product Code:** KLZ
- **Device Name:** Tube, Shunt, Endolymphatic With Valve
- **Regulation:** [21 CFR 874.3850](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3850)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **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](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLZ/K972383.md) | EASY-JET DEVICE | A.Stein - Regulatory Affairs Consulting | Nov 23, 1999 | SESE |

## Top Applicants

- A.Stein - Regulatory Affairs Consulting — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLZ](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLZ)

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