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

    ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

    K Number: K071553 · Decision Sep 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    104

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    Basic Information

    Device Name
    ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
    K Number
    K071553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ndo Surgical, Inc.
    Date Received
    June 6, 2007
    Decision Date
    September 18, 2007
    Product Code
    ODE
    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
    ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

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    Other Clearances by Ndo Surgical, Inc.

    K Number Device Name
    K073671 PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
    K072125 ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
    K032820 MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
    K031262 ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
    K023234 ENDOSCOPIC PLICATION SYSTEM