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

    DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

    K Number: K082097 · Decision Jan 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    533

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    Basic Information

    Device Name
    DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
    K Number
    K082097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corp.
    Date Received
    July 24, 2008
    Decision Date
    January 8, 2010
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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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
    K072930 DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
    K043330 POLYPROPILENE SURGICAL SUTURES
    K043539 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
    K023030 DEMETECH POLYESTER NONABSORBABLE SUTURE
    K023028 DEMETECH NYLON NONABSORBABLE SUTURE
    K023029 DEMETECH SILK NONABSORBABLE SUTURE