Device |
applicator, transurethral, radio frequency, for stress urinary incontinence in women |
Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
Definition |
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility. |
Physical State |
Consists of radio frequency probe and generator and accessories. |
Technical Method |
Functions within a system. |
Target Area |
Bladder neck and proximal urethra |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | NVJ |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4400
|
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 |
Not Third Party Eligible |