Product code OKN

Device name

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Medical specialty

Unknown

Device class

3

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset