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510(k) Data Aggregation

    K Number
    K180134
    Device Name
    Ensizor Monopolar Endoscopic Scissors
    Manufacturer
    Slater Endoscopy, LLC
    Date Cleared
    2018-06-29

    (163 days)

    Product Code
    KGE, OCZ
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Slater Endoscopy, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures. Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.
    Device Description
    The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures. The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.
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    K Number
    K150939
    Device Name
    Ensizor Endoscopic Scissors
    Manufacturer
    SLATER ENDOSCOPY, LLC
    Date Cleared
    2015-06-08

    (62 days)

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

    SLATER ENDOSCOPY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.
    Device Description
    The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection and the cutting of sutures during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue and suture materials during all flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
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    K Number
    K141058
    Device Name
    ENSIZOR ENDOSCOPIC SCISSORS
    Manufacturer
    SLATER ENDOSCOPY, LLC
    Date Cleared
    2014-08-01

    (99 days)

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

    SLATER ENDOSCOPY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.
    Device Description
    The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
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