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510(k) Data Aggregation

    K Number
    K964176
    Device Name
    TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS
    Manufacturer
    TECNO INSTRUMENTS (USA), INC.
    Date Cleared
    1997-08-14

    (300 days)

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

    TECNO INSTRUMENTS (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple (come of have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, opthalmic, plastic and reconstructive surgical procedures. Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.
    Device Description
    REUSABLE BIPOLAR ELECTROSURGICAL FORCEPS
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