Microdebrider, Ent, High Speed, Single Use, Reprocessed
Medical specialty
Ear, Nose, Throat
Device class
1
Regulation number
874.4140
Review panel
EN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.)