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510(k) Data Aggregation

    K Number
    K043383
    Device Name
    N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
    Manufacturer
    PHYSION, INC.
    Date Cleared
    2005-10-27

    (322 days)

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

    PHYSION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed therapeutic and diagnostic agents into the urethra, prostate and vesical cavities with visualization via a cystoscope.
    Device Description
    Not Found
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    K Number
    K022950
    Device Name
    MINIPHYSIONIZER 2.0 AND ELECTRODES
    Manufacturer
    PHYSION, INC.
    Date Cleared
    2003-04-18

    (225 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHYSION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miniphysionzier 2.0 and Electrodes are intended for use in the iontophoretic transdermal administration of ionized medications.
    Device Description
    Not Found
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