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Found 17 results

510(k) Data Aggregation

    K Number
    K251748
    Device Name
    MammoSTAR Biopsy Site Identifier
    Date Cleared
    2025-07-23

    (47 days)

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

    Carbon Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
    Device Description
    MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
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    K Number
    K211590
    Device Name
    Fiducial Marker
    Date Cleared
    2021-06-10

    (17 days)

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

    Carbon Medical Technologies Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
    Device Description
    The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
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    K Number
    K191797
    Device Name
    BiomarC Fiducial Marker
    Date Cleared
    2019-07-29

    (26 days)

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

    Carbon Medical Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
    Device Description
    The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
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    K Number
    K172227
    Device Name
    Endoscopic Injection Needle
    Date Cleared
    2017-08-23

    (29 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carbon Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.
    Device Description
    The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.
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    K Number
    K133148
    Device Name
    BIOMARC COAXIAL NEEDLE
    Date Cleared
    2014-05-13

    (208 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
    Device Description
    The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.
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    K Number
    K132064
    Device Name
    BIOMARC FIDUCIAL MARKER
    Date Cleared
    2014-02-28

    (240 days)

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

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
    Device Description
    The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
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    K Number
    K132708
    Device Name
    BIOMARC FIDUCIAL MARKER
    Date Cleared
    2013-12-20

    (113 days)

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

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biomac Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.
    Device Description
    The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible delivery devices chosen by the user.
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    K Number
    K130678
    Device Name
    BIOMARC GOLD FIDUCIAL MARKER
    Date Cleared
    2013-04-12

    (30 days)

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

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiomarC Gold Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
    Device Description
    The BiomarC Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
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    K Number
    K110772
    Device Name
    BIOMARC FIDUCIAL MARKER
    Date Cleared
    2011-04-28

    (38 days)

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

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
    Device Description
    BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength. BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism.
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    K Number
    K100994
    Device Name
    PRELOADED TISSUE MARKER DEVICE
    Date Cleared
    2010-04-30

    (21 days)

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

    CARBON MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    [Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
    Device Description
    [Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
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