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

    SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200

    K Number: K912447 · Decision Sep 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    8
    Review Days
    116

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    Basic Information

    Device Name
    SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
    K Number
    K912447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Laser, Inc.
    Date Received
    June 3, 1991
    Decision Date
    September 27, 1991
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Medical Laser, Inc.

    K Number Device Name
    K913136 LASER ENDOSCOPE DISC DECOMPRESSION KITS
    K912265 MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
    K912089 MODIFIED SERIES 2100 ENDOSCOPES
    K901464 MEDILASE SERIES 2200 ENDOSCOPE
    K900894 MEDILASE SERIES 2100 ENDOSCOPE
    K900380 MEDILASE 5010 ENDOSCOPE CONSOLE
    K895837 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR