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

    ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

    K Number: K121309 · Decision Sep 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    128

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    Basic Information

    Device Name
    ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
    K Number
    K121309
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Concepts
    Date Received
    May 1, 2012
    Decision Date
    September 6, 2012
    Product Code
    OTJ
    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
    OTJ Laparoscopic Single Port Access Device

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