FDA product code HEN: Caliper, Fetal Head, Ultrasonic
HEN is the FDA product code for caliper, fetal head, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel. Devices under HEN reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Caliper, Fetal Head, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 884.2225 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HEN devices
openFDA lists no recalls for product code HEN.
Frequently asked questions
What is FDA product code HEN?
HEN is the FDA product code for caliper, fetal head, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEN?
Class II, regulation 21 CFR 884.2225. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HEN
- Run a recall and safety report across every HEN manufacturer
- Watch product code HEN 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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