510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NLYClass I

Microdebrider, Ent, High Speed, Single Use, Reprocessed

21 CFR 874.4140 / Ear, Nose, Throat
FDA source (opens on fda.gov)

NLY is the FDA product code for Microdebrider, Ent, High Speed, Single Use, Reprocessed, a class I device type, regulated under 21 CFR 874.4140. FDA's definition for this code reads: "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.)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NLY
Device name
Microdebrider, Ent, High Speed, Single Use, Reprocessed
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.)
Regulation
21 CFR 874.4140
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NLY

By decision year
1 clearance under product code NLY with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NLY by decision year
YearClearances
20141

Applicants with the most clearances

Product code NLY
Applicants holding the most 510(k) clearances under product code NLY
ApplicantClearances
Medline ReNewal1

Companies listing this code with FDA

Companies whose registered establishments list this code