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510(k) Data Aggregation

    K Number
    K240429
    Device Name
    Trilogy Tissue Marker
    Manufacturer
    INRAD Inc.
    Date Cleared
    2024-11-07

    (268 days)

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

    INRAD Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.
    Device Description
    The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.
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    K Number
    K183503
    Device Name
    EasyMark Tissue Marker
    Manufacturer
    INRAD Inc.
    Date Cleared
    2019-10-17

    (304 days)

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

    INRAD Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
    Device Description
    The EasyMark Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker.
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    K Number
    K112945
    Device Name
    ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
    Manufacturer
    INRAD INC.
    Date Cleared
    2011-11-03

    (30 days)

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

    INRAD INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
    Device Description
    The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
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