BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ALPHAXENON LIGHT 180 W AND 300 W

    K Number: K093125 · Decision Jan 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    117

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    Basic Information

    Device Name
    ALPHAXENON LIGHT 180 W AND 300 W
    K Number
    K093125
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gimmi GmbH
    Date Received
    October 2, 2009
    Decision Date
    January 27, 2010
    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 Gimmi GmbH

    K Number Device Name
    K092421 ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
    K081640 GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
    K012869 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
    K012660 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
    K013731 GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03