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

    Gazelle PTFE and Suture Delivery Device

    K Number: K173335 · Decision Feb 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    108

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    Basic Information

    Device Name
    Gazelle PTFE and Suture Delivery Device
    K Number
    K173335
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dura Tap, LLC
    Date Received
    October 23, 2017
    Decision Date
    February 8, 2018
    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 Dura Tap, LLC

    K Number Device Name
    K173644 Gazelle Polypropylene Suture and Delivery Device