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510(k) Data Aggregation

    K Number
    K003965
    Device Name
    MRI SAFE INSTRUMENTS
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2001-03-16

    (84 days)

    Product Code
    GEA
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982472
    Device Name
    GENICON TROCAR
    Manufacturer
    GENICON, LC
    Date Cleared
    1999-02-04

    (204 days)

    Product Code
    GEA
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
    Device Description
    This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated. Trocar Tip: - A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula. Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion. Cannula: - Clear casing for visualization of instrument and tissue passage. . - Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use. - . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap. - . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product. Valve: - . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use. - . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
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