FDA product code NLN: Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
NLN is the FDA product code for drills, burrs, trephines and accessories (simple powered), reprocessed. It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under NLN. The average 510(k) review took 123 days (median 123).
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 (Simple Powered), Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 882.4310 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NLN clearance
Top NLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alliance Medical Corp. | 1 | 2004-11-23 |
Most recent NLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041978 | Alliance Medical Corp. | REPROCESSED DIAMOND BURS | 2004-11-23 | 123 |
Recalls for NLN devices
openFDA lists no recalls for product code NLN.
Frequently asked questions
What is FDA product code NLN?
NLN is the FDA product code for drills, burrs, trephines and accessories (simple powered), reprocessed. It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel.
What device class is NLN?
Class II, regulation 21 CFR 882.4310. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLN?
Across 1 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most NLN clearances?
Alliance Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NLN
- Run a recall and safety report across every NLN manufacturer
- Watch product code NLN 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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