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

    AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT

    K Number: K893707 · Decision Jun 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    218
    Review Days
    28

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    Basic Information

    Device Name
    AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
    K Number
    K893707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    May 18, 1989
    Decision Date
    June 15, 1989
    Product Code
    DRC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRC Trocar

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    K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
    K061095 AUTO SUTUR ENDO GIA STAPLERS
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