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510(k) Data Aggregation

    K Number
    K973068
    Device Name
    KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
    Date Cleared
    1997-11-07

    (81 days)

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

    KARL STORZ ENDOSKOP GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures. These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.
    Device Description
    The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting are manually operated surgical devices. The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is composed of Forward Oblique (30°) Endoscope, Optical Retractor and Optical Dissector, Vein Dissectors, Grasping Forceps, Dissecting and Grasping Forceps, and Hook Scissors, Take-apart™ Dissecting Forceps, Dissecting and Grasping Forceps, and Scissors, Take-apart® Bipolar Forceps, and Suction Coagulating Cannula. The body contact portions of the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting are composed of surgical grade stainless steel, PTFE, Kynar and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
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    K Number
    K961702
    Device Name
    KSEA VAPORIZATION ELECTRODES
    Date Cleared
    1996-08-29

    (119 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARL STORZ ENDOSKOP GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).
    Device Description
    The KSEA vaporization electrodes are manually operated, singleuse instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.
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