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

    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

    K Number: K000537 · Decision Apr 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
    K Number
    K000537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Arc Medical Supplies (Beijing) Co, Ltd.
    Date Received
    February 17, 2000
    Decision Date
    April 27, 2000
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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    Other Clearances by Arc Medical Supplies (Beijing) Co, Ltd.

    K Number Device Name
    K022666 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    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
    K000539 NYLON NONABSORBABLE SURGICAL SUTURES, USP