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

    GRAMSORB SYNTHETIC ABSORBABLE SUTURE

    K Number: K003017 · Decision Mar 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    7
    Review Days
    167

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    Basic Information

    Device Name
    GRAMSORB SYNTHETIC ABSORBABLE SUTURE
    K Number
    K003017
    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
    Gramsmed, LLC
    Date Received
    September 27, 2000
    Decision Date
    March 13, 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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    Other Clearances by Gramsmed, LLC

    K Number Device Name
    K021043 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    K010672 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
    K003590 GRAMS POLYESTER NONABSORBABLE SUTURE
    K003000 GRAMS NYLON NONABSORBABLE SUTURE
    K002999 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    K003001 GRAMS SILK NONABSORBABLE SUTURE