FDA product code NLS: Instrument, Biopsy, Reprocessed
NLS is the FDA product code for instrument, biopsy, reprocessed. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. Devices under NLS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended to obtain samples of tissue by cutting and/or other mechanical means. 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 | Instrument, Biopsy, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLS devices
openFDA lists no recalls for product code NLS.
Frequently asked questions
What is FDA product code NLS?
NLS is the FDA product code for instrument, biopsy, reprocessed. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is NLS?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLS
- Run a recall and safety report across every NLS manufacturer
- Watch product code NLS 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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