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

    OMNISONIC ENDOSCOPIC DEFLECTOR

    K Number: K993445 · Decision Dec 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    55

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    Basic Information

    Device Name
    OMNISONIC ENDOSCOPIC DEFLECTOR
    K Number
    K993445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnisonics Medical Technologies
    Date Received
    October 12, 1999
    Decision Date
    December 6, 1999
    Product Code
    GCM
    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
    GCM Endoscope, Rigid

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    Other Clearances by Omnisonics Medical Technologies

    K Number Device Name
    K083335 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
    K071762 OMNIWAVE ENDOVASCULAR SYSTEM
    K052428 RESOLUTION ENDOVASCULAR SYSTEM
    K041705 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
    K003824 OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
    K993628 OMNISONICS ULTRASONIC PROBES
    K991377 OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER