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

    DemeDIOX Barbed Absorbable Surgical Suture

    K Number: K191361 · Decision Nov 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    5
    Review Days
    170

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    Basic Information

    Device Name
    DemeDIOX Barbed Absorbable Surgical Suture
    K Number
    K191361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corporation
    Date Received
    May 21, 2019
    Decision Date
    November 7, 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 Demetech Corporation

    K Number Device Name
    K201479 DemeMASK
    K190777 DemeTECH DemeFORCE Nonabsorbable Surgical Suture
    K181578 DemeTECH PTFE Nonabsorbable Surgical Suture
    K181582 DemeTECH DemeDIOX absorbable surgical suture