FDA product code NLT: Snare, Flexible, Reprocessed
NLT is the FDA product code for snare, flexible, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under NLT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. 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 | Snare, Flexible, 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 NLT devices
openFDA lists no recalls for product code NLT.
Frequently asked questions
What is FDA product code NLT?
NLT is the FDA product code for snare, flexible, 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 NLT?
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 NLT
- Run a recall and safety report across every NLT manufacturer
- Watch product code NLT 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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