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510(k) Data Aggregation

    K Number
    K082828
    Device Name
    SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
    Manufacturer
    SUTURTEK INCORPORATED
    Date Cleared
    2008-10-14

    (19 days)

    Product Code
    GAQ, GAO
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURTEK INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suturtek 360° Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.
    Device Description
    The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy. The device is sterilized before each use. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the tissue. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are placed in the same manner and then the ends of the suture are tied together in the usual fashion.
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    K Number
    K063603
    Device Name
    SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
    Manufacturer
    SUTURTEK INCORPORATED
    Date Cleared
    2007-02-07

    (66 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURTEK INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuturTek Surgical Steel Suture is intended for use in sternal closure.
    Device Description
    The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.
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    K Number
    K032468
    Device Name
    SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
    Manufacturer
    SUTURTEK INCORPORATED
    Date Cleared
    2003-09-23

    (43 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURTEK INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.
    Device Description
    The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.
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    K Number
    K030227
    Device Name
    SUTURTEK FASTCLOSE SUTURING DEVICE
    Manufacturer
    SUTURTEK INCORPORATED
    Date Cleared
    2003-03-17

    (54 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURTEK INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures. The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures. It is designed to aid in the prevention of suture needle stick injuries.
    Device Description
    The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
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