← Product Code [ETD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD) · K000801

# PC COATED FLUOROPLASTIC VENT TUBES (K000801)

_Gyrus Ent LLC · ETD · Jun 19, 2000 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K000801

## Device Facts

- **Applicant:** Gyrus Ent LLC
- **Product Code:** [ETD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD.md)
- **Decision Date:** Jun 19, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3880
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K000801](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K000801)

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