NLY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Microdebrider, Ent, High Speed, Single Use, Reprocessed

Device class

Class I (low risk)

Regulation

21 CFR 874.4140

Medical specialty

Ear, Nose, Throat

FDA 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.)

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