FDA product code NLE: Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
NLE is the FDA product code for forceps, biopsy, bronchoscope (non-rigid), reprocessed. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. Devices under NLE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Same as BWH except it is reprocessed. 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 | Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for NLE devices
openFDA lists no recalls for product code NLE.
Frequently asked questions
What is FDA product code NLE?
NLE is the FDA product code for forceps, biopsy, bronchoscope (non-rigid), reprocessed. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is NLE?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLE
- Run a recall and safety report across every NLE manufacturer
- Watch product code NLE 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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