NLZ

Bur, Ent, Diamond Coated, Single Use, Reprocessed

Product code

NLZ

Device name

Bur, Ent, Diamond Coated, Single Use, Reprocessed

Device class

Class 1

21 CFR

21 CFR 874.4140

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

FDA classification definition

ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).