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510(k) Data Aggregation

    K Number
    K173043
    Device Name
    Holycon Synthetic Absorbable Sutures
    Date Cleared
    2017-12-14

    (77 days)

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

    Nantong Holycon Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Holycon Synthetic Absorbable Sutures is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
    Device Description
    The Holycon Synthetic Absorbable Sutures are multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. The Holycon Synthetic Absorbable Sutures are composed of PGLA suture and needle. The Holycon Synthetic Absorbable Sutures are composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); they are coated with copolymer of 30% glycolide and 70% lactide and calcium stearate. The PGLA suture is dyed suture. The needles are available in four types: Taper, Cutting, Spatula and Blunt. The material of needles is stainless steel. The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40<861>, USP 40<871> and USP 40 <881>. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
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