Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3930](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3930) → KQL — Tube, Tympanostomy With Semi-Permeable Membrane

# KQL · Tube, Tympanostomy With Semi-Permeable Membrane

_Ear, Nose, Throat · 21 CFR 874.3930 · Class 2_

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

## Overview

- **Product Code:** KQL
- **Device Name:** Tube, Tympanostomy With Semi-Permeable Membrane
- **Regulation:** [21 CFR 874.3930](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3930)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. The tube portion of the device is made of silicone elastomer or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.

## Classification Rationale

Class II. The special control for this device is FDA's “Tympanostomy Tubes, Submission Guidance for a 510(k).”

## Special Controls

The special control for this device is FDA's “Tympanostomy Tubes, Submission Guidance for a 510(k).”

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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