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

    STANDARD ENDOSCOPE

    K Number: K972056 · Decision Jul 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    58

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    Basic Information

    Device Name
    STANDARD ENDOSCOPE
    K Number
    K972056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laser-Optik-Systeme GmbH & Co. KG
    Date Received
    June 2, 1997
    Decision Date
    July 30, 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 Laser-Optik-Systeme GmbH & Co. KG

    K Number Device Name
    K950712 PORTABLE ENDOSCOPY SYSTEM
    K952028 COLD LIGHT SOURCE LOS XL-A 100
    K951829 COLD LIGHT SOURCE LOS 150