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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5510
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K261342Prodeon Medical, Inc. · 510k2026-06-22
K253525Prodeon Medical, Inc. · 510k2026-03-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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