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510(k) Data Aggregation

    K Number
    K243011
    Device Name
    Silicone Urethral Catheter (Silicone Urethral Catheter)
    Manufacturer
    Guangdong Ecan Medical Co., Ltd.
    Date Cleared
    2025-06-16

    (263 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Ecan Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).
    Device Description
    The Silicone Urethral Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon and valve. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid. The device is made of silicone and available in different types (e.g., male, female, Tiemann, 2-way, 3-way etc.) and sizes for adult and pediatric use. The device is for single use and provided with sterile. The indwelling time is no more than 30 days.
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