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

    PC-205 TENCKHOFF CATHETER ROD OBTURATOR

    K Number: K823296 · Decision Jan 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    81
    Applicant Total
    9
    Review Days
    82

    Basic Information

    Device Name
    PC-205 TENCKHOFF CATHETER ROD OBTURATOR
    K Number
    K823296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    MEDIGROUP
    Date Received
    November 5, 1982
    Decision Date
    January 26, 1983
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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