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

    MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

    K Number: K030212 · Decision Mar 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    4
    Review Days
    65

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    Basic Information

    Device Name
    MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K Number
    K030212
    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
    Genzyme Biosurgery
    Date Received
    January 21, 2003
    Decision Date
    March 27, 2003
    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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