FDA product code HFZ: Craniotribe
HFZ is the FDA product code for craniotribe. It is a Class II device, regulated under 21 CFR 884.4500 and reviewed by the Obstetrics and Gynecology panel. Devices under HFZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Craniotribe |
| Device class | Class II |
| Regulation | 21 CFR 884.4500 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HFZ devices
openFDA lists no recalls for product code HFZ.
Frequently asked questions
What is FDA product code HFZ?
HFZ is the FDA product code for craniotribe. It is a Class II device, regulated under 21 CFR 884.4500 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFZ?
Class II, regulation 21 CFR 884.4500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HFZ
- Run a recall and safety report across every HFZ manufacturer
- Watch product code HFZ 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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