FDA product code NLJ: Stripper, Vein, External, Reprocessed
NLJ is the FDA product code for stripper, vein, external, reprocessed. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel. Devices under NLJ 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 | Stripper, Vein, External, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.4885 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for NLJ devices
openFDA lists no recalls for product code NLJ.
Frequently asked questions
What is FDA product code NLJ?
NLJ is the FDA product code for stripper, vein, external, reprocessed. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel.
What device class is NLJ?
Class II, regulation 21 CFR 870.4885. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLJ
- Run a recall and safety report across every NLJ manufacturer
- Watch product code NLJ 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.