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

    Gazelle Polypropylene Suture and Delivery Device

    K Number: K173644 · Decision Feb 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    Gazelle Polypropylene Suture and Delivery Device
    K Number
    K173644
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dura Tap, LLC
    Date Received
    November 27, 2017
    Decision Date
    February 15, 2018
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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    Other Clearances by Dura Tap, LLC

    K Number Device Name
    K173335 Gazelle PTFE and Suture Delivery Device