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U.S. Department of Health and Human Services

Product Classification

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Device transurethral occlusion insert, urinary incontinence-control, female
Definition Transurethral insert for urinary occlusion/control in women with urinary incontinence.
Physical State balloon tipped catheter, insertion device
Technical Method A balloon tipped catheter is inserted into the urethra. Deflation or removal of the device results in fluid movement
Target Area urethra
Review Panel Gastroenterology/Urology
Product CodeOCK
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type PMA
Device Class 3
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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