BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT

    K Number: K915506 · Decision Mar 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    94
    Review Days
    88

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    Basic Information

    Device Name
    LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
    K Number
    K915506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    December 9, 1991
    Decision Date
    March 6, 1992
    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

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