FDA product code NLZ: Bur, Ent, Diamond Coated, Single Use, Reprocessed
NLZ is the FDA product code for bur, ent, diamond coated, single use, reprocessed. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel. Devices under NLZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Bur, Ent, Diamond Coated, Single Use, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 874.4140 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for NLZ devices
openFDA lists no recalls for product code NLZ.
Frequently asked questions
What is FDA product code NLZ?
NLZ is the FDA product code for bur, ent, diamond coated, single use, reprocessed. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel.
What device class is NLZ?
Class I, regulation 21 CFR 874.4140. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLZ
- Run a recall and safety report across every NLZ manufacturer
- Watch product code NLZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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