FDA product code NLY

Microdebrider, Ent, High Speed, Single Use, Reprocessed

Ear, Nose, Throat·Class 1·21 CFR 874.4140
US regulatory classifications
US Product Code (FDA)
NLY
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 874.4140
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.)

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About this record

Microdebrider, Ent, High Speed, Single Use, Reprocessed is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.