Product code
OEK: Water-induced thermotherapy system, benign prostatic hyperplasia
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OEK |
|---|---|
| Device | Water-induced thermotherapy system, benign prostatic hyperplasia |
| Device class | Class II |
| Regulation number | 876.4300 |
| Review panel | General & Plastic Surgery |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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