Product code
POY: Post breast biopsy hemostatic breast compression device
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | POY |
|---|---|
| Device | Post breast biopsy hemostatic breast compression device |
| Device class | Class II |
| Regulation number | 892.1710 |
| Review panel | General & Plastic Surgery |
| Medical specialty | Radiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To achieve and maintain hemostasis of a breast biopsy wound site. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 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