21 CFR 874.4140 — Bur, Ear, Nose And Throat
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4140
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | 1 | 18 | |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | 1 | 1 | |
| NLZ | Bur, Ent, Diamond Coated, Single Use, Reprocessed | 1 | 0 |
