510(k) Report

FDA product code · General and plastic surgery

Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia

OEKClass II21 CFR 876.4300510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of OEK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OEK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OEK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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