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

    SONOCA II ULTRASONIC SURGICAL DEVICE

    K Number: K901737 · Decision Jul 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    SONOCA II ULTRASONIC SURGICAL DEVICE
    K Number
    K901737
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Holl Meditronics, Inc.
    Date Received
    April 17, 1990
    Decision Date
    July 3, 1990
    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 Holl Meditronics, Inc.

    K Number Device Name
    K954171 ARCO-MBC, ARCO MC
    K942095 SONOCA III
    K911600 ILCO INFRARED LIGHT COAGULATOR
    K893924 MOTO-MED RF-II AND PICO
    K893926 SONOCA ULTRASONIC SURGICAL SYSTEM