FDA product code HDE: Hook, Fibroid, Gynecological
HDE is the FDA product code for hook, fibroid, gynecological. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. Devices under HDE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hook, Fibroid, Gynecological |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for HDE devices
openFDA lists no recalls for product code HDE.
Frequently asked questions
What is FDA product code HDE?
HDE is the FDA product code for hook, fibroid, gynecological. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDE?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HDE
- Run a recall and safety report across every HDE manufacturer
- Watch product code HDE 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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