BEUDAMED
    Product Code: MJG FDA class 1 21 CFR 878.4800

    Device, Percutaneous, Biopsy

    General, Plastic Surgery

    The Percutaneous Biopsy Device is a minimally invasive needle-based instrument used to obtain tissue or fluid samples from internal organs or lesions through the skin under image guidance, enabling histological or cytological diagnosis without open surgery. Classified as a Class 1 device under 21 CFR 878.4800 in the General and Plastic Surgery specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    7
    FEI Numbers
    67
    Registration Numbers
    67
    Unique Applicants
    7
    Years Active
    15

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    Basic Information

    Product Code
    MJG
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K080674 PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
    K070836 EXICLIP EXCS-M
    K983647 ECHO-COAT ULTRASOUND NEEDLES
    K955683 RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    K933324 SKIN BIOPSY DEVICE
    K925870 SPACER
    K922919 DYNACYT BIOPSY ASPIRATION DEVICE

    FEI Numbers

    This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.