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

Bur, Ent, Diamond Coated, Single Use, Reprocessed

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

NLZ is the FDA product code for Bur, Ent, Diamond Coated, Single Use, Reprocessed, a class I device type, regulated under 21 CFR 874.4140. FDA's definition for this code reads: "ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NLZ
Device name
Bur, Ent, Diamond Coated, Single Use, Reprocessed
FDA definition
ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLZ.