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

    TX1 TISSUE REMOVAL SYSTEM

    K Number: K101561 · Decision Aug 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    TX1 TISSUE REMOVAL SYSTEM
    K Number
    K101561
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Optisurgical, Inc.
    Date Received
    June 4, 2010
    Decision Date
    August 27, 2010
    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 American Optisurgical, Inc.

    K Number Device Name
    K080803 VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
    K020527 HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
    K953538 RM001 REUSABLE
    K953539 DM001 DISPOSABLE PACK
    K952331 AOI LC-40 PHACOEMULSIFIER