FDA product code OEK: Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
OEK is the FDA product code for water-induced thermotherapy system, benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the General and Plastic Surgery panel. Devices under OEK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia
Classification
| Field | Value |
|---|---|
| Device name | Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for OEK devices
openFDA lists no recalls for product code OEK.
Frequently asked questions
What is FDA product code OEK?
OEK is the FDA product code for water-induced thermotherapy system, benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the General and Plastic Surgery panel.
What device class is OEK?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OEK
- Run a recall and safety report across every OEK manufacturer
- Watch product code OEK 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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