OTOTOME BUR
Device Facts
| Record ID | K792028 |
|---|---|
| Device Name | OTOTOME BUR |
| Applicant | American Sterilizer Co. |
| Product Code | EQJ · Ear, Nose, Throat |
| Decision Date | Oct 26, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4140 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.
