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

    PENTAX Medical Gas/Water Feeding Valve OE-B14

    K Number: K232249 · Decision Dec 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    44
    Review Days
    126

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    Basic Information

    Device Name
    PENTAX Medical Gas/Water Feeding Valve OE-B14
    K Number
    K232249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax of America, Inc.
    Date Received
    July 28, 2023
    Decision Date
    December 1, 2023
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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    Other Clearances by Pentax of America, Inc.

    K Number Device Name
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    K231970 PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
    K231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
    K213235 PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
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