VENTILATION TUBES W/ HYDROGEL COATING
Device Facts
| Record ID | K923353 |
|---|---|
| Device Name | VENTILATION TUBES W/ HYDROGEL COATING |
| Applicant | Microbio-Medics, Inc. |
| Product Code | ETD · Ear, Nose, Throat |
| Decision Date | May 18, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3880 |
| Device Class | Class 2 |
Regulatory Classification
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.
