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

    KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE

    K Number: K942112 · Decision Feb 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    35
    Review Days
    302

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    Basic Information

    Device Name
    KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
    K Number
    K942112
    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 Endoscopy
    Date Received
    May 2, 1994
    Decision Date
    February 28, 1995
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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    K023924 AUTOCON II 200 ELECTROSURGICAL GENERATOR
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    K011700 MODULITH SLK LITHOTRIPTER
    K021776 KSEA QUADRO SWITCH
    K013107 BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
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