BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    Endoform Reconstructive Template

    K Number: K153633 · Decision Mar 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    Endoform Reconstructive Template
    K Number
    K153633
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aroa Biosurgery Limited (Formerly Mesynthes Limited)
    Date Received
    December 18, 2015
    Decision Date
    March 15, 2016
    Product Code
    FTM
    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
    FTM Mesh, Surgical

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    Other Clearances by Aroa Biosurgery Limited (Formerly Mesynthes Limited)

    K Number Device Name
    K153632 Endoform Reconstructive Template