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510(k) Data Aggregation

    K Number
    K033191
    Device Name
    SOHNIKS
    Date Cleared
    2004-03-09

    (160 days)

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

    SOHNIKS ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.
    Device Description
    The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in non-sterile and must be cleaned and sterilized by the user prior to use. The parts that contact the body are composed of surgical grade stainless steel, which has a long history of biocompatibility for human use.
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    K Number
    K023783
    Device Name
    SOHNIKS
    Date Cleared
    2003-02-07

    (87 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOHNIKS ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sohniks Endoscopy Arthroscopes are intended for use by qualified surgeons during procedures of small and large joints. The intended use for Sohniks Endoscopy, Inc.'s arthroscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of orthopedic joints, otolaryngology, thinology, endoscopic plastic and reconstructive surgery. Our arthroscopes are intended for use in the shoulder, wrist, knee, ankle, elbow, and jaw and visualization of the hip joint to diagnose disease and removal of loose bodies.
    Device Description
    The Söhniks Arthroscopes are reusable manually operated surgical devices that are provided in 0. 30. 45. and 70 degree direction of view. The Arthroscopes are provide non-sterile and must be cleaned and sterilized by the user prior to each use. The components that contact the body are composed of surgical grade stainless steel, which is commonly used in medical devices and has a long history of biocompatibility for human use.
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