OKN — Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy Class III
FDA product code OKN covers "Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OKN
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- 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.