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

FDA product code QKA · 3 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5510
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-06-25 – 2026-06-22

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.

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