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510(k) Data Aggregation

    K Number
    K193608
    Device Name
    EBERLE Shaver System C3 and Accessories
    Date Cleared
    2021-01-15

    (386 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Eberle GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EBERLE shaver system C3 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, cutting and resecting of fibrous tissue, cartilage tissue and bone. The EBERLE shaver system accessories are designed to use with the EBERLE shaver system for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.
    Device Description
    The EBERLE Shaver System C3 and shaver blades is a powered instrument system and consists of a control unit, a foot switch, handpiece(s), and accessories - associated sterile shaver blades for single use. The control unit C3 includes three software systems. The other components of the shaver system C3 e.q. handpiece or footswitch consist only of hardware components. All software systems on the control unit are running on microcontrollers. The Eberle Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector consist of Polyoxymethylen (POM), the tubes consists of stainless steel. The shaver blades are provided in a sterile packaging and are intended for single use. The shaver blades are sterilized using EO sterilization with a Sterilization Assurance Level (SAL) of 10-6. The Eberle Handpieces with switch buttons have three buttons to select the direction of rotation depending on the user assignment of functionalities to the buttons. It consists of Stainless Steel and Aluminum. The Eberle Drill and the Saw - Handpieces also consist of Stainless Steel and Aluminum. The Drill Handpiece has two buttons to select the direction of rotation and the saw has an operator lever. All these components are designed, constructed and intended to be operated exclusively as a system. EBERLE Shaver System C2 and C3 use the same shaver blades. The shaver blades are identical with the once already cleared under the predicated device K092977 - Eberle Shaver System Accessories. Eberle has added addition blades to provide a broader offering. EBERLE Shaver System C2 and C3 have common handpieces and use the same kind of adapters.
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