NLY

Microdebrider, Ent, High Speed, Single Use, Reprocessed

Product code

NLY

Device name

Microdebrider, Ent, High Speed, Single Use, Reprocessed

Device class

Class 1

21 CFR

21 CFR 874.4140

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)

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