BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Stone Retrieval Balloon Catheter

    K Number: K253013 · Decision May 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    231

    Basic Information

    Device Name
    Disposable Stone Retrieval Balloon Catheter
    K Number
    K253013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Soudon Medical Technology Co., Ltd.
    Date Received
    September 19, 2025
    Decision Date
    May 8, 2026
    Product Code
    GCA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GCA), ordered by most recent decision date.

    Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

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    SpyGlass Discover Balloon Dilation Catheter

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    Stone Retrieval Balloon

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    Fusion Quattro Extraction Balloon

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    Tri-Ex Extraction Balloon with Multiple Sizing

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    Other Clearances by Zhejiang Soudon Medical Technology Co., Ltd.

    K Number Device Name
    K253056 Disposable Stone Extraction Basket
    K232450 Disposable Hemostatic Clips
    K232442 Disposable Endoscope Injection Needles
    K232476 Disposable Sphincterotome