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

    EASY LOOP, MODEL EZL-01

    K Number: K040110 · Decision Mar 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    64

    Basic Information

    Device Name
    EASY LOOP, MODEL EZL-01
    K Number
    K040110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4270
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOOLS FOR SURGERY, LLC
    Date Received
    January 20, 2004
    Decision Date
    March 24, 2004
    Product Code
    EZP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EZP Rod, Colostomy

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    COLOPLAST OSTOMY ROD, MODEL 12814

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    Other Clearances by TOOLS FOR SURGERY, LLC

    K Number Device Name
    K040109 HEMORRHAGE OCCLUDER PIN