FDA product code NLP: Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
NLP is the FDA product code for drills, burrs, trephines, and accessories (powered compound), reprocessed. It is a Class II device, regulated under 21 CFR 882.4305 and reviewed by the Neurology panel. Devices under NLP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
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 | Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 882.4305 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLP devices
openFDA lists no recalls for product code NLP.
Frequently asked questions
What is FDA product code NLP?
NLP is the FDA product code for drills, burrs, trephines, and accessories (powered compound), reprocessed. It is a Class II device, regulated under 21 CFR 882.4305 and reviewed by the Neurology panel.
What device class is NLP?
Class II, regulation 21 CFR 882.4305. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLP
- Run a recall and safety report across every NLP manufacturer
- Watch product code NLP 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.