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510(k) Data Aggregation

    K Number
    K062125
    Device Name
    SUPERSTITCH 5F, 12F, AND EL
    Manufacturer
    Date Cleared
    2006-10-19

    (86 days)

    Product Code
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.
    Device Description
    The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.
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    K Number
    K053482
    Device Name
    SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
    Manufacturer
    Date Cleared
    2005-12-27

    (13 days)

    Product Code
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.
    Device Description
    SuperStitch GW Models 06-15-04-GW; 08-15-04-GW
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    K Number
    K020940
    Device Name
    SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
    Manufacturer
    Date Cleared
    2002-04-17

    (26 days)

    Product Code
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
    Device Description
    The SuperStitch Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots. Optional accessories for use with the SuperStitch include the KnotPusher for advancing the knot to the wound site and the Kwiknot knot tying device. The principal difference between the modified SuperStitch and the cleared SuperStitch is a change in one of the shaft materials. The Sutura SuperStitch is a prescription device, restricted to use by or on the order of physicians. The Sutura SuperStitch is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.
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    K Number
    K012865
    Device Name
    SUPERSTITCH VASCULAR SUTURING DEVICE
    Manufacturer
    Date Cleared
    2001-09-25

    (29 days)

    Product Code
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
    Device Description
    The SuperStitch® Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch® applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots, Optional accessories for use with the SuperStitch® include the KnotPusher™ for advancing the knot to the wound site and the Kwiknot™ knot tying device. The principal differences between the modified SuperStitch® and the cleared SuperStitch® are: (1) changes made within the operating mechanism to improve manufacturability; (2) the addition of longer lengths to accommodate longer (i.e., 25cm) sheaths; (3) change in package to a single sterile barrier; (4) the inclusion of a modified KnotPusher™ accessory that is packaged with the SuperStitch® (5) a change in one of the cannula materials; and (6) the addition of a smaller (6 French) size for compatibility with 6 French procedural sheaths. The Sutura SuperStitch® is a prescription device, restricted to use by or on the order of physicians. The Sutura SuperStitch® is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.
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    K Number
    K994087
    Device Name
    SUPERSTITCH
    Manufacturer
    Date Cleared
    2000-03-01

    (89 days)

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

    SUTURA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
    Device Description
    The SuperStitch® device is designed for use with or without an access device (e.g., trocar, sheath, or cannula) depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. SuperStitch® applies one nonabsorbable sterile surgical suture. The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.
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