Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5510
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.