FDA product code NLO: Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
NLO is the FDA product code for drills, burrs, trephines and accessories (manual), reprocessed. It is a Class II device, regulated under 21 CFR 882.4300 and reviewed by the Neurology panel. Devices under NLO 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 (Manual), Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 882.4300 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLO devices
openFDA lists no recalls for product code NLO.
Frequently asked questions
What is FDA product code NLO?
NLO is the FDA product code for drills, burrs, trephines and accessories (manual), reprocessed. It is a Class II device, regulated under 21 CFR 882.4300 and reviewed by the Neurology panel.
What device class is NLO?
Class II, regulation 21 CFR 882.4300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLO
- Run a recall and safety report across every NLO manufacturer
- Watch product code NLO 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.