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

    AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE

    K Number: K011375 · Decision Jun 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    207
    Review Days
    56

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    Basic Information

    Device Name
    AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K Number
    K011375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap, Inc.
    Date Received
    May 4, 2001
    Decision Date
    June 29, 2001
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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