OEKClass II

Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia

21 CFR 876.4300 / Gastroenterology, Urology

OEK is the FDA product code for Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia, a class II device type, regulated under 21 CFR 876.4300. FDA's definition for this code reads: "Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OEK
Device name: Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
FDA definition: Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia
Regulation: 21 CFR 876.4300
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OEK.

Recent clearances

Product code OEK

FDA records hold no clearances under product code OEK.

Recent recalls

Product code OEK

FDA records show no recalls under product code OEK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)