DeviceClearance

Product code MNG— Gastroenterology, Urology

FEMASSIST FLEXIBLE

Classification name
External Urethral Occluder, Urinary Incontinence-Control, Female
Device class
Class 1
Regulation
21 CFR 876.5160
Advisory panel
Gastroenterology, Urology
Total cleared
7
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code MNG under 21 CFR 876.5160, via openFDA

Market context for product code MNG

FDA has cleared 7 devices under product code MNG between 1996 and 2001, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code MNG

Recent clearances under product code MNG

Data sourced from openFDA. This site is unofficial and independent of the FDA.