Product code
PKY: Implant, dermal, for aesthetic use in the hands
FDA product code · Class III · General & Plastic Surgery
Key facts
| Product code | PKY |
|---|---|
| Device | Implant, dermal, for aesthetic use in the hands |
| Device class | Class III |
| Review panel | General & Plastic Surgery |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For hand augmentation to correct volume loss in the dorsum of the hands. |
At a glance
- None 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