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510(k) Data Aggregation

    K Number
    K230836
    Device Name
    SchurSign Tissue Marker
    Manufacturer
    Date Cleared
    2024-01-23

    (302 days)

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

    SurgMark GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under supervision of a healthcare professional · The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
    Device Description
    SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location. The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate. The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger. SchurSign is available in seven different sizes: | Model | Diameter (mm) | Length (mm) | |------------------|---------------|-------------| | SchurSign 1.5-5 | 1.5 | 5 | | SchurSign 1.5-8 | 1.5 | 8 | | SchurSign 2.0-5 | 2.0 | 5 | | SchurSign 2.0-8 | 2.0 | 8 | | SchurSign 2.0-10 | 2.0 | 10 | | SchurSign 2.5-10 | 2.5 | 10 | | SchurSign 3.0-10 | 3.0 | 10 |
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