FDA product code OOA: Hemorrhoid Prevention Pressure Wedge
OOA is the FDA product code for hemorrhoid prevention pressure wedge. It is a Class II device, regulated under 21 CFR 884.5200 and reviewed by the Obstetrics and Gynecology panel. Devices under OOA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Classification
| Field | Value |
|---|---|
| Device name | Hemorrhoid Prevention Pressure Wedge |
| Device class | Class II |
| Regulation | 21 CFR 884.5200 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OOA devices
openFDA lists no recalls for product code OOA.
Frequently asked questions
What is FDA product code OOA?
OOA is the FDA product code for hemorrhoid prevention pressure wedge. It is a Class II device, regulated under 21 CFR 884.5200 and reviewed by the Obstetrics and Gynecology panel.
What device class is OOA?
Class II, regulation 21 CFR 884.5200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OOA
- Run a recall and safety report across every OOA manufacturer
- Watch product code OOA 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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