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

    INSIGHT 4000 ENDOSCOPE

    K Number: K000252 · Decision Oct 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    INSIGHT 4000 ENDOSCOPE
    K Number
    K000252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Insight Instruments Mfg., Inc.
    Date Received
    January 27, 2000
    Decision Date
    October 17, 2000
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPA Endoilluminator

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