LBL · Tube, Tympanostomy, Porous Polyethylene
Ear, Nose, Throat · 21 CFR 874.3880 · Class 2
Overview
| Product Code | LBL |
|---|---|
| Device Name | Tube, Tympanostomy, Porous Polyethylene |
| Regulation | 21 CFR 874.3880 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900218 | J&S HDL CHOLESTEROL PRECIPITATING REAGENT | J.S. Medical Assoc. | Jun 18, 1990 | SESE |
Top Applicants
- J.S. Medical Assoc. — 1 clearance
