FDA product code OKN

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Unknown·Class 3·21 CFR
US regulatory classifications
US Product Code (FDA)
OKN
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.