External Urethral Occluder, Urinary Incontinence-Control, Female

MNG · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5160

Classification

FDA Product Code: MNG
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.5160
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown