Product code
PFU: Tissue processing kit
FDA product code · Not Classified · Pathology
Key facts
| Product code | PFU |
|---|---|
| Device | Tissue processing kit |
| Device class | Not Classified |
| Review panel | Pathology |
| Submission type | Enforcement Discretion |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the preparation of human tissue specimens for frozen sectioning and histological examination. |
At a glance
- None 510(k) clearances
- None 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