FDA product code KBP: Hook, Tonsil Suturing
KBP is the FDA product code for hook, tonsil suturing. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under KBP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hook, Tonsil Suturing |
| 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 KBP devices
openFDA lists no recalls for product code KBP.
Frequently asked questions
What is FDA product code KBP?
KBP is the FDA product code for hook, tonsil suturing. 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 KBP?
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 KBP
- Run a recall and safety report across every KBP manufacturer
- Watch product code KBP 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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