Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K190155
    Device Name
    FibermarX Radiopaque Tissue Marker
    Date Cleared
    2019-02-27

    (28 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Viscus Biologics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FibermarX™ Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.
    Device Description
    The device is a sterile, single-patient-use, barium sulfate infused non-absorbable polymer monofilament that is visible on standard radiographs (x-ray, CT, mammography). FibermarX™ is passed through soft tissue and tied into place during open, percutaneous, or arthroscopic/laparoscopic/endoscopic procedures and standard surgeon's knots or a continuous running outline are used to quickly mark the soft tissue for subsequent imaging or for radiotherapy target localization.
    Ask a Question

    Ask a specific question about this device

    K Number
    K170026
    Device Name
    Radiopaque Tissue Marker
    Date Cleared
    2017-06-02

    (150 days)

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

    Viscus Biologics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
    Device Description
    The device is a sterile, single-patient-use, barium sulfate infused polypropylene suture that is radiopaque using standard radiographs (x-ray, mammography). The device is placed into soft tissue sites during open, percutaneous, or endoscopic procedures and standard surgeon's knots are tied to quickly and inexpensively mark the soft tissue so that the integrity and location of the marked soft tissue can be evaluated.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1