DeviceClearance

Product code NLY— Ear, Nose, Throat

MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES

Classification name
Microdebrider, Ent, High Speed, Single Use, Reprocessed
Device class
Class 1
Regulation
21 CFR 874.4140
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

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.)”

— U.S. Food and Drug Administration, device classification record for product code NLY under 21 CFR 874.4140, via openFDA

Market context for product code NLY

FDA has cleared 1 device under product code NLY, all in 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NLY

Recent clearances under product code NLY

Data sourced from openFDA. This site is unofficial and independent of the FDA.