Product code
OCL: Surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
FDA product code · Class II · Cardiovascular
Key facts
| Product code | OCL |
|---|---|
| Device | Surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue |
| Device class | Class II |
| Regulation number | 878.4400 |
| Review panel | Cardiovascular |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 10–99 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