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

    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE

    K Number: K141007 · Decision Sep 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    160

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    Basic Information

    Device Name
    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
    K Number
    K141007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corp.
    Date Received
    April 18, 2014
    Decision Date
    September 25, 2014
    Product Code
    GAQ
    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
    GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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    Other Clearances by Demetech Corp.

    K Number Device Name
    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
    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