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

    WEXLER ENDOSCOPE ACCESSORIES

    K Number: K110121 · Decision May 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    112

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    Basic Information

    Device Name
    WEXLER ENDOSCOPE ACCESSORIES
    K Number
    K110121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microsurgical Laboratories,Inc.Dba Wexler Surgical
    Date Received
    January 18, 2011
    Decision Date
    May 10, 2011
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Microsurgical Laboratories,Inc.Dba Wexler Surgical

    K Number Device Name
    K110148 WEXLER VASCULAR CLAMP SERIES
    K053255 NEXUS LIGATING CLIP