FDA product code OEJ: Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
OEJ is the FDA product code for transurethral electrosurgical unit, 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 OEJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia
Classification
| Field | Value |
|---|---|
| Device name | Transurethral Electrosurgical Unit, 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 OEJ devices
openFDA lists no recalls for product code OEJ.
Frequently asked questions
What is FDA product code OEJ?
OEJ is the FDA product code for transurethral electrosurgical unit, 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 OEJ?
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 OEJ
- Run a recall and safety report across every OEJ manufacturer
- Watch product code OEJ 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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