OKN

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Product code: OKN
Device name: Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OKN

Classification and pathway per current FDA publications. Data from openFDA (CC0).