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

    KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR

    K Number: K951995 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    11
    Review Days
    26

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    Basic Information

    Device Name
    KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
    K Number
    K951995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoskop GmbH
    Date Received
    April 28, 1995
    Decision Date
    May 24, 1995
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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    Other Clearances by Karl Storz Endoskop GmbH

    K Number Device Name
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    K961702 KSEA VAPORIZATION ELECTRODES
    K953368 LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
    K943713 TORCARS,CANNULAE,SHEATHS,OBTURATORS
    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 →