OEK

Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia

Product code: OEK
Device name: Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
Device class: Class 2
21 CFR: 21 CFR 876.4300
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)

FDA classification definition

Thermotherapy and dilation 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: OEK

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