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510(k) Data Aggregation

    K Number
    K092977
    Device Name
    EBERLE SHAVER SYSTEM ACCESSORIES
    Date Cleared
    2010-09-29

    (369 days)

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

    EFS EBERLE FEINWERKTECHNISCHE SYSTEME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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 conducted by qualified surgeons only.
    Device Description
    The Eberle Shaver System Accessories are manufactured by EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG in Germany. They are developed for surgical use in the field of arthroscopy and should only be used by trained personnel in designated institutions. The Eberle Single Use 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 POM, the tubes consists of stainless steel. The Blades are provided in a sterile packaging and are intended for single use (not autoclave- reusable). The Eberle Hand Piece with Switch has three buttons to select the direction of rotation. It consists of Stainless Steel and Aluminum. The Eberle Drill- and the Saw- Hand Piece also consist of Stainless Steel and Aluminum. The Drill has two buttons to select the direction of rotation and the Saw hast a operator lever. All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System C2.
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    K Number
    K061134
    Device Name
    EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
    Date Cleared
    2006-09-01

    (130 days)

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

    EFS EBERLE FEINWERKTECHNISCHE SYSTEME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EBERLE Shaver System C2 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, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.
    Device Description
    The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile). All these components are designed, constructed and intended to be operated exclusively as a unit.
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