MUK

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Product code

MUK

Device name

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Device class

Class 2

21 CFR

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence

Definition text from the FDA device classification database (U.S. federal government work, public domain).