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510(k) Data Aggregation

    K Number
    K162617
    Device Name
    NobleStitch EL
    Date Cleared
    2017-04-06

    (198 days)

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

    NOBLES MEDICAL TECHNOLOGIES II, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NobleStich EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.
    Device Description
    The NobleStich EL device is a single-use surgical device, indicated for use in direct contact within the vascular and cardiovascular system. The NobleStitch EL device may be used by insertion through an access device (e.g. trocar, sheath or cannula), already in place following diagnostic or interventional procedures.
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    K Number
    K113494
    Device Name
    NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
    Date Cleared
    2012-04-19

    (146 days)

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

    NOBLES MEDICAL TECHNOLOGIES II, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.
    Device Description
    The NobleStitch™ EL, MR. and TA 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 KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.
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    K Number
    K113763
    Device Name
    SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
    Date Cleared
    2012-03-16

    (86 days)

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

    NOBLES MEDICAL TECHNOLOGIES II, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
    Device Description
    The SRM-Stitch™ 8F version is 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, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.
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