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510(k) Data Aggregation

    K Number
    K212049
    Device Name
    Oclet TDS 1000
    Manufacturer
    TendoNova Corporation
    Date Cleared
    2022-03-08

    (251 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TendoNova Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ocelot TDS 1000 is indicated for use during surgical procedures when fragmentation or debridement of soft tissue is desired.
    Device Description
    The Ocelot TDS 1000 is a portable, handheld battery-powered device that consists of a Reusable Drive Unit (RDU), a charging station for the RDU, a sterile Disposable Unit (DU) that houses the cutting tool assembly, and an optional application that displays real-time operating data. The Ocelot TDS 1000 is comprised of a unit that mechanically interacts with tissue and an app that provides real-time device operating data. A battery charging unit is provided to recharge the battery.
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