BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ERCP CATHETER, HYDROPHILIC COATED

    K Number: K932205 · Decision Jan 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    125
    Review Days
    242

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    Basic Information

    Device Name
    ERCP CATHETER, HYDROPHILIC COATED
    K Number
    K932205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    May 6, 1993
    Decision Date
    January 3, 1994
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

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