21 CFR 874.4250 — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4250

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece2913rd Party
Innolitics

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