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

    Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector

    K Number: K143186 · Decision Dec 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    39
    Review Days
    43

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    Basic Information

    Device Name
    Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
    K Number
    K143186
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erbe USA, Inc.
    Date Received
    November 5, 2014
    Decision Date
    December 18, 2014
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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