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510(k) Data Aggregation

    K Number
    K990996
    Device Name
    GENYX MEDICAL INJECTION NEEDLE
    Manufacturer
    GENYX MEDICAL, INC.
    Date Cleared
    1999-06-18

    (85 days)

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

    GENYX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
    Device Description
    The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. The Genyx Injection Needle materials are similar to those used in the predicate device. The Genyx Injection Needle is substantially equivalent to both predicate devices in that they all contain a stainless steel shaft and a luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue.
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