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

    TROCARS,CANNULAE,SHEATHS,OBTURATORS

    K Number: K943697 · Decision Sep 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    4
    Applicant Total
    11
    Review Days
    47

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    Basic Information

    Device Name
    TROCARS,CANNULAE,SHEATHS,OBTURATORS
    K Number
    K943697
    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
    July 29, 1994
    Decision Date
    September 14, 1994
    Product Code
    ODB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODB Endoscopic Contamination Prevention Sheath

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    Other Clearances by Karl Storz Endoskop GmbH

    K Number Device Name
    K973068 KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
    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
    K943816 TROCARS,CANNULAE, SHEATHS
    Search all 11 clearances from Karl Storz Endoskop GmbH →