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External Urethral Occluder, Urinary Incontinence-Control, Female

FDA product code MNG · 7 cleared devices

Class 1 Gastroenterology, Urology
Regulation
21 CFR 876.5160
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1996-05-08 – 2001-04-30

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.

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