QKA

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Product code

QKA

Device name

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Device class

Class 2

21 CFR

21 CFR 876.5510

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-06-22.

2 summaries are archived here for direct download.