FDA product code NLB: Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
NLB is the FDA product code for trocar, tracheal, laryngeal, sinus, reprocessed. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under NLB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Same as KBG, KAB, and KCI but need one code for 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 | Trocar, Tracheal, Laryngeal, Sinus, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLB devices
openFDA lists no recalls for product code NLB.
Frequently asked questions
What is FDA product code NLB?
NLB is the FDA product code for trocar, tracheal, laryngeal, sinus, reprocessed. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is NLB?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLB
- Run a recall and safety report across every NLB manufacturer
- Watch product code NLB 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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