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 Code | QKA |
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 |