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

    STORZ N5941 SERIES MEDICAL GRADE TUBING

    K Number: K940352 · Decision Apr 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    76
    Applicant Total
    101
    Review Days
    79

    Basic Information

    Device Name
    STORZ N5941 SERIES MEDICAL GRADE TUBING
    K Number
    K940352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STORZ INSTRUMENT CO.
    Date Received
    January 25, 1994
    Decision Date
    April 14, 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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