Product code
MPN: Tissue adhesive for the topical approximation of skin
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | MPN |
|---|---|
| Device | Tissue adhesive for the topical approximation of skin |
| Device class | Class II |
| Regulation number | 878.4010 |
| 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 | Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k). |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ 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