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

    MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE

    K Number: K050947 · Decision Jun 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    218
    Review Days
    47

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    Basic Information

    Device Name
    MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    K Number
    K050947
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    April 15, 2005
    Decision Date
    June 1, 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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    K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
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