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

    ENDOMEDIX Y-ADAPTER

    K Number: K934170 · Decision Jan 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    7
    Review Days
    137

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    Basic Information

    Device Name
    ENDOMEDIX Y-ADAPTER
    K Number
    K934170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endomedix
    Date Received
    August 27, 1993
    Decision Date
    January 11, 1994
    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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