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510(k) Data Aggregation

    K Number
    K110121
    Device Name
    WEXLER ENDOSCOPE ACCESSORIES
    Manufacturer
    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL
    Date Cleared
    2011-05-10

    (112 days)

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

    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.
    Device Description
    The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.
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    K Number
    K110148
    Device Name
    WEXLER VASCULAR CLAMP SERIES
    Manufacturer
    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL
    Date Cleared
    2011-04-19

    (91 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
    Device Description
    The Wexler Vascular Clamp Series is a family of vascular clamps, both stainless steel and titanium alloy, used during surgical procedures. The clips are supplied nonsterile and are chosen based on the dimensions, features and technological characteristics desired.
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    K Number
    K053255
    Device Name
    NEXUS LIGATING CLIP
    Manufacturer
    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL
    Date Cleared
    2006-03-14

    (113 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.
    Device Description
    The Nexus Ligating Clip is a titanium clip used during surgical procedures. The clips are supplied sterile in four sizes: small, medium-large, and large; six clips per cartridge. The size of clip should be chosen based on experience, judgment, and needs, ensuring that the tissue to be occluded fits completely within the clip. The devices are heart-shaped to provide a firm grip on the structure to be ligated, and there are transverse grooves on the inner surface of each clip to resist slippage.
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