510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OKNClass III

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Unknown
FDA source (opens on fda.gov)

OKN is the FDA product code for Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OKN
Device name
Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OKN.