Product code
PHU: Intra-abdominal pressure monitoring device
FDA product code · Unclassified · General & Plastic Surgery
Key facts
| Product code | PHU |
|---|---|
| Device | Intra-abdominal pressure monitoring device |
| Device class | Unclassified |
| Review panel | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 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