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510(k) Data Aggregation

    K Number
    K212810
    Device Name
    MONOFIX PGCL, knotless wound closure device
    Manufacturer
    Samyang Holdings Corp., Ltd.
    Date Cleared
    2022-08-05

    (336 days)

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

    Samyang Holdings Corp., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.
    Device Description
    MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.
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