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

    LAPAROMED CHOLANGIOGRAM VACUUM DEVICE

    K Number: K910218 · Decision Apr 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    10
    Review Days
    81

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    Basic Information

    Device Name
    LAPAROMED CHOLANGIOGRAM VACUUM DEVICE
    K Number
    K910218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Laparomed Corp.
    Date Received
    January 17, 1991
    Decision Date
    April 8, 1991
    Product Code
    GCX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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    K910219 LAPAROMED CHOLANGIOGRAM DEVICE
    K905722 SUTURE APPLIER DEVICE