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510(k) Data Aggregation

    K Number
    K172672
    Device Name
    Endoscopic Applicator, 41 cm
    Date Cleared
    2017-10-06

    (31 days)

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

    Micromedics Inc. (d/b/a Nordson Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.
    Device Description
    Not Found
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    K Number
    K162077
    Device Name
    Laparoscopic Spray Applicator with Spinning Luers
    Date Cleared
    2016-08-11

    (15 days)

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

    MICROMEDICS INC. (D/B/A NORDSON MEDICAL)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for the application of two non-homogenous liquids.
    Device Description
    The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar. The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts: - . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately) - Stainless steel shaft connecting hub to Pebax ● - Flexible Pebax portion connecting stainless steel shaft to distal tip - Fixed-position distal tip. ● Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media. The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.
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    K Number
    K151543
    Device Name
    Graft Delivery Device with Integrated Stylet
    Date Cleared
    2015-07-07

    (29 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micromedics Inc. (d/b/a Nordson Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
    Device Description
    The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements. The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel. The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.
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