Product code
OKN: Hyperthermia system, bladder cancer treatment, with chemotherapy
FDA product code · Class III · Gastroenterology/Urology
Key facts
| Product code | OKN |
|---|---|
| Device | Hyperthermia system, bladder cancer treatment, with chemotherapy |
| Device class | Class III |
| Review panel | Gastroenterology/Urology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug. For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors. |
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