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

    GRAMS POLYESTER NONABSORBABLE SUTURE

    K Number: K003590 · Decision Mar 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    7
    Review Days
    104

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    Basic Information

    Device Name
    GRAMS POLYESTER NONABSORBABLE SUTURE
    K Number
    K003590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gramsmed, LLC
    Date Received
    November 21, 2000
    Decision Date
    March 5, 2001
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by Gramsmed, LLC

    K Number Device Name
    K021043 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    K010672 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
    K003017 GRAMSORB SYNTHETIC ABSORBABLE SUTURE
    K003000 GRAMS NYLON NONABSORBABLE SUTURE
    K002999 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    K003001 GRAMS SILK NONABSORBABLE SUTURE