FDA product code HFA: Amnioscope, Transabdominal (Fetoscope) (And Accessories)
HFA is the FDA product code for amnioscope, transabdominal (fetoscope) (and accessories). It is a HDE device, regulated under 21 CFR 884.1600 and reviewed by the Obstetrics and Gynecology panel. Devices under HFA reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Amnioscope, Transabdominal (Fetoscope) (And Accessories) |
| Device class | HDE |
| Regulation | 21 CFR 884.1600 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | Unclassified |
Recalls for HFA devices
openFDA lists no recalls for product code HFA.
Frequently asked questions
What is FDA product code HFA?
HFA is the FDA product code for amnioscope, transabdominal (fetoscope) (and accessories). It is a HDE device, regulated under 21 CFR 884.1600 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFA?
HDE, regulation 21 CFR 884.1600. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code HFA
- Run a recall and safety report across every HFA manufacturer
- Watch product code HFA 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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