FDA product code HDH: Needle, Cerclage, Gynecological
HDH is the FDA product code for needle, cerclage, gynecological. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. Devices under HDH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Cerclage, Gynecological |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for HDH devices
openFDA lists no recalls for product code HDH.
Frequently asked questions
What is FDA product code HDH?
HDH is the FDA product code for needle, cerclage, gynecological. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDH?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HDH
- Run a recall and safety report across every HDH manufacturer
- Watch product code HDH 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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