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510(k) Data Aggregation

    K Number
    K982287
    Device Name
    ASLAN SENSOR MODULAR INSTRUMENT
    Date Cleared
    1998-08-06

    (37 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASLAN MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aslan Modular Instruments are intended to be used by a qualified surgeon for grasping, manipulating, cutting and/or coagulating tissue in endoscopic (videoscopic) procedures.
    Device Description
    Aslan Modular Instruments comprise a modular line of re-usable instruments consisting of various size shafts, handles of various configurations, and a number of interchangeable tips which can be used in laparoscopic surgery for grasping, cutting, and cauterizing delicate tissues using monopolar electrocautery. The tips and shafts, sized to fit through 5mm, 10mm or 12mm cannulae, range in length from 12cm to 45cm. For ease of cleaning, the tip, together with its actuating rod, can be completely removed from the shaft, and the tip-and-shaft assembly may be completely removed from the handle.
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    K Number
    K954864
    Device Name
    ASLAN MODULAR INSTRUMENT
    Date Cleared
    1996-02-09

    (109 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASLAN MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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