Microdebrider, Ent, High Speed, Single Use, Reprocessed
NLY · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4140
Classification
FDA Product Code
NLY
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.4140
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.)