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

    POLYPROPILENE SURGICAL SUTURES

    K Number: K043330 · Decision May 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    10
    Review Days
    165

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    Basic Information

    Device Name
    POLYPROPILENE SURGICAL SUTURES
    K Number
    K043330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corp.
    Date Received
    December 2, 2004
    Decision Date
    May 16, 2005
    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 Demetech Corp.

    K Number Device Name
    K141007 DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
    K123940 DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
    K130083 DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
    K082097 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
    K072930 DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
    K043539 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
    K023030 DEMETECH POLYESTER NONABSORBABLE SUTURE
    K023028 DEMETECH NYLON NONABSORBABLE SUTURE
    K023029 DEMETECH SILK NONABSORBABLE SUTURE