FDA product code OKN: Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
OKN is the FDA product code for hyperthermia system, bladder cancer treatment, with chemotherapy. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under OKN reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OKN devices
openFDA lists no recalls for product code OKN.
Frequently asked questions
What is FDA product code OKN?
OKN is the FDA product code for hyperthermia system, bladder cancer treatment, with chemotherapy. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is OKN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OKN
- Run a recall and safety report across every OKN manufacturer
- Watch product code OKN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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