BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GOLNIT Non-aborbable PTFE Surgical Suture

    K Number: K192088 · Decision Sep 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    GOLNIT Non-aborbable PTFE Surgical Suture
    K Number
    K192088
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Antarma, LLC Dba Golnit Sutures
    Date Received
    August 5, 2019
    Decision Date
    September 4, 2019
    Product Code
    NBY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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    Other Clearances by Antarma, LLC Dba Golnit Sutures

    K Number Device Name
    K212888 Golnit Nylon Monofilament Suture