MNG

7 FDA 510(k) clearances · Product code

FDA profile

Official device name

External Urethral Occluder, Urinary Incontinence-Control, Female

Device class

Class I (low risk)

Regulation

21 CFR 876.5160

Medical specialty

Gastroenterology, Urology

FDA 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.

Adverse events (MAUDE)

1997: 49 · 1999: 2 · 2000: 15 · 2001: 10 · 2002: 5 · 2003: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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