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510(k) Data Aggregation

    K Number
    K193268
    Device Name
    APrioCore Plus
    Manufacturer
    AprioMed AB
    Date Cleared
    2020-02-27

    (93 days)

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

    AprioMed AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.
    Device Description
    AprioCore plus is a manually operated, sterile, single use, semi-automatic, spring-loaded biopsy needle. AprioCore plus is provided in a variety of sizes (gauge and length) and is compatible with AprioMed devices Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle.
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    K Number
    K181756
    Device Name
    Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
    Manufacturer
    AprioMed AB
    Date Cleared
    2018-12-18

    (169 days)

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

    AprioMed AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
    Device Description
    Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use. Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.
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    K Number
    K150625
    Device Name
    Morrison Steerable Needle
    Manufacturer
    APRIOMED AB
    Date Cleared
    2015-06-09

    (90 days)

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

    APRIOMED AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.
    Device Description
    The sterile, single use, Morrison Steerable Needle consists of the housing, a rotating lever which controls the deflection of the needle tip, the slide, the collar which transfers tensile force from the slide to the core wire; the tendon wire (core wire) which transfers tensile force from the collar to distal tip of the tubing; the stainless steel tubing which ends in a Menghini like needle tip on the distal end and a luer lock fitting on the proximal end.
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