FDA product code KBB: Rongeur, Nasal
KBB is the FDA product code for rongeur, nasal. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under KBB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Rongeur, Nasal |
| 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) exempt |
Recalls for KBB devices
openFDA lists no recalls for product code KBB.
Frequently asked questions
What is FDA product code KBB?
KBB is the FDA product code for rongeur, nasal. 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 KBB?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KBB
- Run a recall and safety report across every KBB manufacturer
- Watch product code KBB 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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