FDA product code HEG: Set, Anesthesia, Pudendal
HEG is the FDA product code for set, anesthesia, pudendal. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel. Devices under HEG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Set, Anesthesia, Pudendal |
| Device class | Class II |
| Regulation | 21 CFR 884.5100 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HEG devices
openFDA lists no recalls for product code HEG.
Frequently asked questions
What is FDA product code HEG?
HEG is the FDA product code for set, anesthesia, pudendal. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEG?
Class II, regulation 21 CFR 884.5100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HEG
- Run a recall and safety report across every HEG manufacturer
- Watch product code HEG 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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