Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K212888
    Device Name
    Golnit Nylon Monofilament Suture
    Manufacturer
    Antarma LLC dba Golnit Sutures
    Date Cleared
    2022-03-31

    (202 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Antarma LLC dba Golnit Sutures

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.
    Device Description
    The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.
    Ask a Question
    K Number
    K192088
    Device Name
    GOLNIT Non-aborbable PTFE Surgical Suture
    Manufacturer
    Antarma LLC dba Golnit Sutures
    Date Cleared
    2019-09-04

    (30 days)

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

    Antarma LLC dba Golnit Sutures

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
    Device Description
    The 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. The final configuration of the GOLNIT Non-absorbable PTFE Surgical Suture consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles. The suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The GOLNIT Non-absorbable PTFE Surgical Suture is sterilized by ethylene oxide and is intended for single use only.
    Ask a Question

    Page 1 of 1