Device |
electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue |
Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
Definition |
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence |
Physical State |
radiofrequency generator, applicator, software |
Technical Method |
A generator supplies radiofrequency energy through a connected applicator with an electrode tip |
Target Area |
pelvic tissue |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Gastroenterology/Urology |
Product Code | MUK |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
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 |