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

    PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

    K Number: K022666 · Decision Oct 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K Number
    K022666
    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
    Arc Medical Supplies (Beijing) Co, Ltd.
    Date Received
    August 9, 2002
    Decision Date
    October 9, 2002
    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 Arc Medical Supplies (Beijing) Co, Ltd.

    K Number Device Name
    K022664 PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K000542 PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
    K000541 SILK NONABSORBABLE SURGICAL SUTURES, USP
    K000540 POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
    K000537 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
    K000539 NYLON NONABSORBABLE SURGICAL SUTURES, USP