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

    GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC

    K Number: K021043 · Decision Jun 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    7
    Review Days
    81

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    Basic Information

    Device Name
    GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    K Number
    K021043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gramsmed, LLC
    Date Received
    April 1, 2002
    Decision Date
    June 21, 2002
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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    Other Clearances by Gramsmed, LLC

    K Number Device Name
    K010672 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
    K003017 GRAMSORB SYNTHETIC ABSORBABLE SUTURE
    K003590 GRAMS POLYESTER NONABSORBABLE SUTURE
    K003000 GRAMS NYLON NONABSORBABLE SUTURE
    K002999 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    K003001 GRAMS SILK NONABSORBABLE SUTURE