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510(k) Data Aggregation

    K Number
    K190264
    Device Name
    Viola
    Manufacturer
    Date Cleared
    2019-08-15

    (188 days)

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

    MEDITIME Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate
    Device Description
    The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs distributed along the suture with a barb size of 0.567mm. The device is designed with small bi-directional barbs along the long axis of the suture monofilament to prevent sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots after tissue approximation. It is available in diameter size USP 0 through 4-0 in various lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA suture is sterilized by ethylene oxide gas and packed each set in a poly bag.
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