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

    MEDILASE 5010 ENDOSCOPE CONSOLE

    K Number: K900380 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    8
    Review Days
    109

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    Basic Information

    Device Name
    MEDILASE 5010 ENDOSCOPE CONSOLE
    K Number
    K900380
    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
    January 26, 1990
    Decision Date
    May 15, 1990
    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
    K912447 SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
    K912089 MODIFIED SERIES 2100 ENDOSCOPES
    K901464 MEDILASE SERIES 2200 ENDOSCOPE
    K900894 MEDILASE SERIES 2100 ENDOSCOPE
    K895837 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR