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

    ENDOSCOPIC LIGHT SOURCE XL180/L3

    K Number: K023468 · Decision Jan 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    ENDOSCOPIC LIGHT SOURCE XL180/L3
    K Number
    K023468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    World of Medicine Lemke GmbH
    Date Received
    October 16, 2002
    Decision Date
    January 14, 2003
    Product Code
    GCT
    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
    GCT Light Source, Endoscope, Xenon Arc

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    Other Clearances by World of Medicine Lemke GmbH

    K Number Device Name
    K024251 SIGHTFIX
    K021717 ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
    K021456 ER150/M2
    K020889 ENDOSCOPIC LIGHT SOURCE XL202/L3
    K020336 ENDOSCOPIC CAMERA MC404/C3
    K014158 ENDOSCOPIC CAMERA TC804/C4