FDA product code NLX: Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
NLX is the FDA product code for needle, pneumoperitoneum, spring loaded, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under NLX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated for reuse/reprocessing. 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 | Needle, Pneumoperitoneum, Spring Loaded, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NLX devices
openFDA lists no recalls for product code NLX.
Frequently asked questions
What is FDA product code NLX?
NLX is the FDA product code for needle, pneumoperitoneum, spring loaded, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NLX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLX
- Run a recall and safety report across every NLX manufacturer
- Watch product code NLX 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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