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

    IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES

    K Number: K933410 · Decision Dec 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    35
    Applicant Total
    9
    Review Days
    533

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
    K Number
    K933410
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Best Industries
    Date Received
    July 15, 1993
    Decision Date
    December 30, 1994
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IWJ), ordered by most recent decision date.

    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    PGK DEVICE (MODIFIED)

    FDA 510(k)
    FDA Class 1 ·Radiology

    REGANES RADIONUCLIDE SEED MAGAZINE

    FDA 510(k)
    FDA Class 1 ·Radiology

    N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000

    FDA 510(k)
    FDA Class 1 ·Radiology

    WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET

    FDA 510(k)
    FDA Class 1 ·Radiology

    NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all

    Other Clearances by Best Industries

    K Number Device Name
    K940121 IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
    K940119 ROYAL MARSDEN GOLD GRAIN GUN
    K932242 RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
    K930570 RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
    K924290 BEST INDUSTRIES CARTRIDGE & GUN
    K924261 RADIOACTIVE CESIUM-131 SEEDS/SOURCES
    K912170 RADIOACTIVE IODINE-125 SOURCES
    K910862 VARIOUS TEMPLATE APPLICATORS