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U.S. Department of Health and Human Services

Product Classification
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Device temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
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.
Physical State The implant is nitinol and pre-mounted on a dedicated guide wire. It expands following deployment. It is removed using a Foley catheter.
Technical Method The implant provides continuous pressure through a self-expanding nitinol device that is placed at the site of the bladder neck and between the obstructed prostatic lobes for 5–7 days.
Target Area Prostatic urethra.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQKA
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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