BEUDAMED
    Product Code: IWA FDA class 2 21 CFR 892.5730

    Source, Wire, Iridium, Radioactive

    Radiology

    A radioactive iridium wire source is a brachytherapy implant or applicator component consisting of iridium-192 radioactive wire used in interstitial or intracavitary radiation therapy to deliver localized doses of radiation to tumors. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWA, regulated under 21 CFR 892.5730, within the Radiology medical specialty. This device is eligible for third party 510(k) review.

    View on FDA
    510(k)s
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    6
    Years Active
    14

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    Basic Information

    Product Code
    IWA
    Device Class
    FDA class 2
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K915253 IR-192 IMPLANT, MODIFICATION
    K894409 CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
    K874895 IR-192 IMPLANT
    K850382 IRIDIUM SEEDS
    K844248 IR-192 IMPLANT
    K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
    K850163 IRIDIUM 192 WIRES
    K771878 IRIDIUM 192 WIRES & PINS