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

    PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.

    K Number: K022664 · Decision Sep 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    7
    Review Days
    32

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    Basic Information

    Device Name
    PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K Number
    K022664
    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
    Arc Medical Supplies (Beijing) Co, Ltd.
    Date Received
    August 9, 2002
    Decision Date
    September 10, 2002
    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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    Other Clearances by Arc Medical Supplies (Beijing) Co, Ltd.

    K Number Device Name
    K022666 PDO (POLYDIOXANONE) MONOFILAMENT 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