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510(k) Data Aggregation

    K Number
    K160744
    Device Name
    LOOK PTFE Suture
    Manufacturer
    Surgical Specialties Corporation
    Date Cleared
    2016-07-13

    (118 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Specialties Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
    Device Description
    The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White).
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    K Number
    K141778
    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Date Cleared
    2014-07-30

    (28 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL SPECIALTIES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.
    Device Description
    The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter
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    K Number
    K132268
    Device Name
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH
    Date Cleared
    2013-08-23

    (32 days)

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

    SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ PDO Knotless Tissue-Closure Device comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 2 through 3-0 in various lengths affixed to various needle types.
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