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

    OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI

    K Number: K003824 · Decision Mar 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    8
    Review Days
    87

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    Basic Information

    Device Name
    OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
    K Number
    K003824
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnisonics Medical Technologies
    Date Received
    December 11, 2000
    Decision Date
    March 8, 2001
    Product Code
    LFL
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFL Instrument, Ultrasonic Surgical

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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
    K993628 OMNISONICS ULTRASONIC PROBES
    K993445 OMNISONIC ENDOSCOPIC DEFLECTOR
    K991377 OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER