Product code
PNU: Pressure wedge, perianal, for reduction of cesarean delivery
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | PNU |
|---|---|
| Device | Pressure wedge, perianal, for reduction of cesarean delivery |
| Device class | Class II |
| Regulation number | 884.5210 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database