Otological Ventilation Tubes
510(k) K802638
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802638 | Date12 Nov 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ETD
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3880
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
Otological ventilation tubes are devices used to provide ventilation and drainage of the middle ear. They are classified as tympanostomy tubes under FDA device classification.
This device received FDA 510(k) clearance (K802638) on November 12, 1980, and is classified as a Class II medical device under regulation 874.3880. It is supplied by Santa Barbara Medco, Inc. and is intended for use in ear, nose, and throat procedures.
Other devices from Santa Barbara Medco, Inc.
Questions
AI-generated answers, 26 Sep 2026
What are otological ventilation tubes used for?
Otological ventilation tubes are used to provide ventilation and drainage of the middle ear, helping to equalize pressure and prevent fluid buildup in tympanostomy procedures.
Who manufactures these otological ventilation tubes?
These otological ventilation tubes are manufactured by Santa Barbara Medco, Inc., as specified in the device authorization data.
How are these ventilation tubes supplied and regulated?
The devices are supplied by Santa Barbara Medco, Inc. and received FDA 510(k) clearance (K802638) on November 12, 1980, classified as Class II under regulation 874.3880.