Product code
PVZ: Non-stainless steel needle
FDA product code · Class II · General Hospital
Key facts
| Product code | PVZ |
|---|---|
| Device | Non-stainless steel needle |
| Device class | Class II |
| Regulation number | 880.5570 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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