Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K173110
    Device Name
    GRAFTSITE
    Manufacturer
    Summit Medical Ltd.
    Date Cleared
    2018-05-18

    (231 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Summit Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Assistance in the delivery of local anaesthetic after hamstring ligament reconstruction procedures
    Device Description
    GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6 mm and an outer diameter of 4.0 mm, sized to fit down the hamstring harvest site. It is rounded and blocked at the patient end and has a 6% female luer at the user end. There are lateral eyes over a length at the patient end of the catheter. A buttoned stylet consisting of a rigid stainless steel rod of diameter slightly less than the bore of the catheter, functions to stiffen the device. GRAFTSITE can be used to directly administer a bolus of the users chosen local anesthetic, via injection down the lumen of the catheter, into the terminus of the gutter at the site of comorbidity.
    Ask a Question
    K Number
    K170388
    Device Name
    ANCHORMAN Tibial Ligament Fixation Device
    Manufacturer
    Summit Medical Ltd.
    Date Cleared
    2017-07-25

    (167 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Summit Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction
    Device Description
    ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and functions via the looping of a biological or artificial tendon graft through the loop component of the device. The tendon graft is then pulled through the tibial and femoral tunnels. The wing components of the device rest on the tibial cortex, facilitating tensioning on the femoral side (if required). The device then provides tibial suspensory fixation, supporting the graft until aperture healing occurs and the graft integrates with the bone, at which point the device does not bear load and is redundant.
    Ask a Question
    K Number
    K024097
    Device Name
    SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
    Manufacturer
    SUMMIT MEDICAL LTD.
    Date Cleared
    2003-02-14

    (64 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUMMIT MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
    Device Description
    The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polvethylene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging. The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.
    Ask a Question
    K Number
    K022477
    Device Name
    SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
    Manufacturer
    SUMMIT MEDICAL LTD.
    Date Cleared
    2002-10-25

    (88 days)

    Product Code
    CAK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUMMIT MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.
    Device Description
    The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.
    Ask a Question
    K Number
    K022489
    Device Name
    SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
    Manufacturer
    SUMMIT MEDICAL LTD.
    Date Cleared
    2002-10-09

    (72 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUMMIT MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
    Device Description
    The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient. The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag. Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.
    Ask a Question

    Page 1 of 1