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510(k) Data Aggregation

    K Number
    K123061
    Device Name
    ACE MONOPOLAR ATTACHMENT
    Manufacturer
    BIOECONEER INC.
    Date Cleared
    2013-08-13

    (316 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOECONEER INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.
    Device Description
    The ACE Monopolar Attachment is used with compatible ERBE Electrosurgical Generator (ESU) Systems which deliver High Frequency (HF) energy through the electrode tip of the ACE Monopolar Attachment for coagulation and cutting of soft tissue. The ACE Monopolar Attachment is an electrode tip, made of stainless steel, and compatible with marketed plastic insulation handle. The compatible ERBE Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The Monopolar Attachment is provided single-use.
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