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

    MEDILASE SERIES 2100 ENDOSCOPE

    K Number: K900894 · Decision Jun 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    115

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    Basic Information

    Device Name
    MEDILASE SERIES 2100 ENDOSCOPE
    K Number
    K900894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Laser, Inc.
    Date Received
    February 27, 1990
    Decision Date
    June 22, 1990
    Product Code
    GCQ
    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
    GCQ Endoscope, Flexible

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    Other Clearances by Medical Laser, Inc.

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    K912447 SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
    K912089 MODIFIED SERIES 2100 ENDOSCOPES
    K901464 MEDILASE SERIES 2200 ENDOSCOPE
    K900380 MEDILASE 5010 ENDOSCOPE CONSOLE
    K895837 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR