FDA product code HDN: Dilator, Cervical, Expandable
HDN is the FDA product code for dilator, cervical, expandable. It is a Class III device, regulated under 21 CFR 884.4250 and reviewed by the Obstetrics and Gynecology panel. Devices under HDN reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Cervical, Expandable |
| Device class | Class III |
| Regulation | 21 CFR 884.4250 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HDN devices
openFDA lists no recalls for product code HDN.
Frequently asked questions
What is FDA product code HDN?
HDN is the FDA product code for dilator, cervical, expandable. It is a Class III device, regulated under 21 CFR 884.4250 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDN?
Class III, regulation 21 CFR 884.4250. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HDN
- Run a recall and safety report across every HDN manufacturer
- Watch product code HDN 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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