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

    R-PORT LAPAROSCOPIC ACCESS DEVICE

    K Number: K070158 · Decision Aug 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    218

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    Basic Information

    Device Name
    R-PORT LAPAROSCOPIC ACCESS DEVICE
    K Number
    K070158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Concepts
    Date Received
    January 17, 2007
    Decision Date
    August 23, 2007
    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 Advanced Surgical Concepts

    K Number Device Name
    K232701 Guardenia (GAR-1)
    K192898 PneumoLiner
    K121309 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
    K111407 TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
    K110004 ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
    K101794 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
    K073719 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
    K073170 R-PORT II LAPAROSCOPIC ACCESS DEVICE