FDA product code HDZ: Knife, Cervical Cone
HDZ is the FDA product code for knife, cervical cone. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. Devices under HDZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Knife, Cervical Cone |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HDZ devices
openFDA lists no recalls for product code HDZ.
Frequently asked questions
What is FDA product code HDZ?
HDZ is the FDA product code for knife, cervical cone. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDZ?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HDZ
- Run a recall and safety report across every HDZ manufacturer
- Watch product code HDZ 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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