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510(k) Data Aggregation

    K Number
    K160602
    Device Name
    JustRight Surgical Vessel Sealing System
    Manufacturer
    JustRight Surgical
    Date Cleared
    2016-06-23

    (113 days)

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

    JustRight Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required. The device is contraindicated for use in ENT procedures.
    Device Description
    The JustRight Surgical® Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight™ Sealer instruments. The JustRight™ Sealer is a hand held ring handle design with either a 10 cm or a 20 cm shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
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    K Number
    K132472
    Device Name
    JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Date Cleared
    2014-02-11

    (188 days)

    Product Code
    GDW, GAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    JUSTRIGHT SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JustRight™ 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Device Description
    The JustRight™ 5mm Stapler places two 25mm staggered rows of titanium staples while simultaneously dividing the tissue between the two staple rows. The unformed staple size is 2mm from staple backspan to staple leg tip. The system is provided with a stapler handle with one pre-loaded staple cartridge and reload cartridges are provided separately to allow for multiple staple line applications within one surgical procedure. The JustRight™ Stapler is compatible for introduction and use through a 5mm cannula sleeve and the stapler handle has a rotation knob to allow for 360° rotation of the staple cartridge.
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    K Number
    K123662
    Device Name
    THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Date Cleared
    2013-05-22

    (175 days)

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

    JUSTRIGHT SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
    Device Description
    The JustRight Surgical™ Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight Sealer instruments. The Sealer is a hand held ring handle design with either a 10 cm or a 20 cm Shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
    Ask a Question

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