Product code
PMC: Scalp cooling system
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | PMC |
|---|---|
| Device | Scalp cooling system |
| Device class | Class II |
| Regulation number | 878.4360 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 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