FDA product code PNU: Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PNU is the FDA product code for pressure wedge, perianal, for reduction of cesarean delivery. It is a Class II device, regulated under 21 CFR 884.5210 and reviewed by the Obstetrics and Gynecology panel. Devices under PNU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Classification
| Field | Value |
|---|---|
| Device name | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery |
| Device class | Class II |
| Regulation | 21 CFR 884.5210 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for PNU devices
openFDA lists no recalls for product code PNU.
Frequently asked questions
What is FDA product code PNU?
PNU is the FDA product code for pressure wedge, perianal, for reduction of cesarean delivery. It is a Class II device, regulated under 21 CFR 884.5210 and reviewed by the Obstetrics and Gynecology panel.
What device class is PNU?
Class II, regulation 21 CFR 884.5210. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PNU
- Run a recall and safety report across every PNU manufacturer
- Watch product code PNU 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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