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U.S. Department of Health and Human Services

Product Classification

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Device external urethral occluder, urinary incontinence-control, female
Regulation Description Urological clamp for males.
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.
Physical State Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.
Technical Method Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.
Target Area female urinary meatus
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeMNG
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.5160
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm] 
Third Party Review Not Third Party Eligible
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