LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173922
    Device Name
    C-PTFETM Surgical Suture
    Manufacturer
    CP Medical Inc.
    Date Cleared
    2018-03-26

    (90 days)

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

    CP Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.
    Device Description
    The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014
    Ask a Question

    Page 1 of 1