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

    POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE

    K Number: K041048 · Decision Jun 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    43

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    Basic Information

    Device Name
    POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K Number
    K041048
    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
    Internacional Farmaceutica, S.A. DE C.V.
    Date Received
    April 22, 2004
    Decision Date
    June 4, 2004
    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 Internacional Farmaceutica, S.A. DE C.V.

    K Number Device Name
    K072859 ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
    K072863 ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
    K040282 ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
    K913185 STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
    K911354 STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
    K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
    K905287 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
    K905286 IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
    K905285 IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES