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

    INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM

    K Number: K992262 · Decision Oct 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
    K Number
    K992262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Indigo Medical, Inc.
    Date Received
    July 6, 1999
    Decision Date
    October 4, 1999
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

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    Other Clearances by Indigo Medical, Inc.

    K Number Device Name
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    K963081 INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS
    K955758 INDIGO MEDICAL MODEL IDL 830E
    K954195 INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS