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510(k) Data Aggregation

    K Number
    K052900
    Device Name
    QUILL NONABSORBABLE NYLON BARBED SUTURE
    Manufacturer
    QUILL MEDICAL, INC.
    Date Cleared
    2005-11-28

    (45 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUILL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill® Nonabsorbable Nylon Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
    Device Description
    The Ouill® Nonabsorbable Nylon Barbed Suture is a monofilament, flexible thread prepared from long chain aliphatic polymers Nylon 6 and Nylon 6,6 (per 21 CFR 878.5020). It is available sterile, dyed black (logwood extract per 21 CFR 73.1410), dyed blue (FD&C Blue No. 2 per 21 CFR 74.3102) or undyed in various suture diameters, lengths and needle configurations in USP Sizes 2, 1, 0, 2-0, 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament. The Quill® Nonabsorbable Nylon Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Nylon Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Nylon Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
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    K Number
    K052373
    Device Name
    QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
    Manufacturer
    QUILL MEDICAL, INC.
    Date Cleared
    2005-09-26

    (27 days)

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

    QUILL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
    Device Description
    The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament. The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
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    K Number
    K051609
    Device Name
    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    Manufacturer
    QUILL MEDICAL, INC.
    Date Cleared
    2005-08-04

    (48 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUILL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
    Device Description
    The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue. The Quill® Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Synthetic Absorbable Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quil® Synthetic Absorbable Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
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    K Number
    K042075
    Device Name
    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    Manufacturer
    QUILL MEDICAL, INC.
    Date Cleared
    2004-10-26

    (85 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUILL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ Synthetic Absorbable Barbed Sutures are indicated to close easily approximated edges of dermis where use of absorbable sutures is appropriate.
    Device Description
    The Quill™ Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths and needle configurations. The Quill™ Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissues. The Quill™ Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface imbedded in the tissues after the surgeon suture pierces the skin and appropriately places the suture within the tissues. The barbs on the Quill suture form an alternative method than knots in conventional suture for holding the two ends of a suture together.
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