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

    QUICK SEEDER

    K Number: K913293 · Decision Oct 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    35
    Applicant Total
    43
    Review Days
    447

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    Basic Information

    Device Name
    QUICK SEEDER
    K Number
    K913293
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mick Radio-Nuclear Instruments, Inc.
    Date Received
    July 24, 1991
    Decision Date
    October 13, 1992
    Product Code
    IWJ
    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
    IWJ System, Applicator, Radionuclide, Manual

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    K150979 CT/MR Compatible M.A.C. Interstitial GYN Template
    K142597 Vienna System
    K122840 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
    K063382 HDR CT COMPATIBLE SPLIT RING APPLICATOR
    K063381 CT COMPATIBLE F/S/D APPLICATORS
    K052351 HDR IORT SHIELDED APPLICATOR
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    K040704 MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
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