BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING

    K Number: K973068 · Decision Nov 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    11
    Review Days
    81

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    Basic Information

    Device Name
    KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
    K Number
    K973068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoskop GmbH
    Date Received
    August 18, 1997
    Decision Date
    November 7, 1997
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Karl Storz Endoskop GmbH

    K Number Device Name
    K961702 KSEA VAPORIZATION ELECTRODES
    K953368 LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
    K943713 TORCARS,CANNULAE,SHEATHS,OBTURATORS
    K951995 KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
    K943053 KSEA SEMM TISSUR PUNCH
    K943435 CHOLANGIOGRAPHY SET
    K944823 KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES
    K943904 RIGID TELESCOPES
    K943697 TROCARS,CANNULAE,SHEATHS,OBTURATORS
    K943816 TROCARS,CANNULAE, SHEATHS
    Search all 11 clearances from Karl Storz Endoskop GmbH →