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

    PDS Barbed Suture, PDO MAXX Threads

    K Number: K190245 · Decision Jun 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    PDS Barbed Suture, PDO MAXX Threads
    K Number
    K190245
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pdo Max, Inc.
    Date Received
    February 6, 2019
    Decision Date
    June 4, 2019
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Pdo Max, Inc.

    K Number Device Name
    K210871 PDO Max Suture with Dual Needle