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510(k) Data Aggregation

    K Number
    K970817
    Device Name
    MICROMARK CLIP
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Date Cleared
    1997-09-11

    (189 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPSYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location. It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
    Device Description
    The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.
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    K Number
    K970565
    Device Name
    MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Date Cleared
    1997-03-28

    (43 days)

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

    BIOPSYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.
    Device Description
    The Mammotome is comprised of a disposable needle instrument housing. The Mammotome probe may be used with imaging guidance (such as ultrasound, X-ray, and CT), and it may be either stereotactically mounted or hand held depending on physician preference and the type of tissue sampled. The disposable Mammotome probes are available in various sizes and lengths. The probe components include an outer trocar cannula and a sliding inner hollow coaxial cutter. The trocar cannula incorporates a distal sampling notch and a proximal notch which forms the tissue retrieval chamber. The sampling notch thumbwheel is used to manually turn and orientate the sampling notch as desired.
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    K Number
    K963015
    Device Name
    SURGICAL STAPLE MARKER DEVICE (MODIFY)
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Date Cleared
    1996-10-07

    (74 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPSYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.
    Device Description
    The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.
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    K Number
    K960019
    Device Name
    RETRACTOR ARM CLAMP
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Date Cleared
    1996-02-09

    (38 days)

    Product Code
    FWZ
    Regulation Number
    878.4950
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPSYS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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