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510(k) Data Aggregation

    K Number
    K160316
    Device Name
    SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
    Manufacturer
    M.D.L. S.r.l.
    Date Cleared
    2016-10-27

    (265 days)

    Product Code
    KNW, FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.D.L. S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · SemiCut Semi-Automatic Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. · Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tisues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Themy Automatic Biopsy Needle is also indicated to provide for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality. · Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone. · Easy Cut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone. · MDL Biopsy Needle is intended for soft tissue core biopsy with Palium Reusable Automatic Biopsy Device. The device is not intended for use in bone. · Coaxial Introducer Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.
    Device Description
    The M.D.L. S.r.l. Soft Tissues Biopsy Devices and Accessories include semi-automatic spring powered guns (disposable and reusable). Biopsy needle and cannula accessories are provided in a variety of sizes, designed to work with the manufacturer's semi-automatic guns to obtain and deliver a soft tissue core or aspirate sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.
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