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510(k) Data Aggregation

    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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