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510(k) Data Aggregation

    K Number
    K163049
    Device Name
    GOLNIT Non-Absorbable PTFE Surgical Suture
    Manufacturer
    Antarma dba Golnit Sutures
    Date Cleared
    2017-06-21

    (232 days)

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

    Antarma dba Golnit Sutures

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.
    Device Description
    GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0. The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple. GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible. GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.
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