Device |
laparoscopic bladder-neck suspension instrument, stress urinary incontinence |
Regulation Description |
Gynecologic laparoscope and accessories. |
Definition |
For female urinary stress incontinence due to hypermobility |
Physical State |
may include: template assembly, suture retriever, suture cutter, suture placement system |
Technical Method |
Bladder neck suspension using sutures |
Target Area |
bladder neck |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Gastroenterology/Urology |
Product Code | OCQ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.1720
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|