FDA product code HFH: Coagulator, Hysteroscopic (And Accessories)
HFH is the FDA product code for coagulator, hysteroscopic (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel. Devices under HFH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Coagulator, Hysteroscopic (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4160 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HFH devices
openFDA lists no recalls for product code HFH.
Frequently asked questions
What is FDA product code HFH?
HFH is the FDA product code for coagulator, hysteroscopic (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFH?
Class II, regulation 21 CFR 884.4160. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HFH
- Run a recall and safety report across every HFH manufacturer
- Watch product code HFH 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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