MNG

External Urethral Occluder, Urinary Incontinence-Control, Female

Product code

MNG

Device name

External Urethral Occluder, Urinary Incontinence-Control, Female

Device class

Class 1

21 CFR

21 CFR 876.5160

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

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