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510(k) Data Aggregation

    K Number
    K102608
    Device Name
    SECURMARK BIOPSY SITE MARKING SYSTEM
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
    Date Cleared
    2010-10-08

    (28 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue. The SecurMark Biopsy Site Marking System is intended for use with the manual method of deployment. It can be visualized under various imaging modalities such as ultrasound, x-ray, magnetic resonance, direct visualization, and others. This system is intended for single patient use only.
    Device Description
    The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and deployment device. The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the deployment device.
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    K Number
    K072913
    Device Name
    SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
    Date Cleared
    2008-01-04

    (84 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
    Device Description
    The SeCurMark family of Tissue Site Marking Systems is composed of two components: - . an implantable component, composed of a bioabsorbable and permanent component, and - a deployment device utilized for placement of the implantable component at the site of . interest. This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.
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