BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    neoClose PDS

    K Number: K173917 · Decision Nov 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    321

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    Basic Information

    Device Name
    neoClose PDS
    K Number
    K173917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neosurgical, Ltd.
    Date Received
    December 22, 2017
    Decision Date
    November 8, 2018
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Neosurgical, Ltd.

    K Number Device Name
    K142903 neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
    K131688 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
    K123280 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL