FDA product code HBP: Clip, Implanted Malleable
HBP is the FDA product code for clip, implanted malleable. It is a Class II device, regulated under 21 CFR 882.5225 and reviewed by the Neurology panel. Devices under HBP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Implanted Malleable |
| Device class | Class II |
| Regulation | 21 CFR 882.5225 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for HBP devices
openFDA lists no recalls for product code HBP.
Frequently asked questions
What is FDA product code HBP?
HBP is the FDA product code for clip, implanted malleable. It is a Class II device, regulated under 21 CFR 882.5225 and reviewed by the Neurology panel.
What device class is HBP?
Class II, regulation 21 CFR 882.5225. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HBP
- Run a recall and safety report across every HBP manufacturer
- Watch product code HBP 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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