FDA product code HEC: Insufflator, Vaginal
HEC is the FDA product code for insufflator, vaginal. It is a Class I device, regulated under 21 CFR 884.5920 and reviewed by the Obstetrics and Gynecology panel. Devices under HEC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Vaginal |
| Device class | Class I |
| Regulation | 21 CFR 884.5920 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for HEC devices
openFDA lists no recalls for product code HEC.
Frequently asked questions
What is FDA product code HEC?
HEC is the FDA product code for insufflator, vaginal. It is a Class I device, regulated under 21 CFR 884.5920 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEC?
Class I, regulation 21 CFR 884.5920. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HEC
- Run a recall and safety report across every HEC manufacturer
- Watch product code HEC 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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