NVJ

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Product code

NVJ

Device name

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

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)

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

FDA classification 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.

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