BEUDAMED
    Product Code: MIJ FDA class 1 21 CFR 878.4800

    Needle, Tumor Localization

    General, Plastic Surgery

    The Tumor Localization Needle is a thin needle or wire used to mark the location of a non-palpable lesion, such as a breast or soft tissue tumor, prior to surgical excision, enabling surgeons to precisely identify and remove the target tissue. Classified as a Class 1 device under 21 CFR 878.4800 within the General and Plastic Surgery specialty, it is subject only to general controls and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MIJ
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.