OEJ

Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia

Product code: OEJ
Device name: Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
Device class: Class 2
21 CFR: 21 CFR 876.4300
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)

FDA classification definition

Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OEJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).