FDA product code NLV: Electrode, Flexible Suction Coagulator, Reprocessed
NLV is the FDA product code for electrode, flexible suction coagulator, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under NLV reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. This device is indicated 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 | Electrode, Flexible Suction Coagulator, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NLV devices
openFDA lists no recalls for product code NLV.
Frequently asked questions
What is FDA product code NLV?
NLV is the FDA product code for electrode, flexible suction coagulator, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is NLV?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLV
- Run a recall and safety report across every NLV manufacturer
- Watch product code NLV 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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