BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    NAJA Gastrointestinal Catheter

    K Number: K223890 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    171

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    Basic Information

    Device Name
    NAJA Gastrointestinal Catheter
    K Number
    K223890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chess Medical, Inc.
    Date Received
    December 27, 2022
    Decision Date
    June 16, 2023
    Product Code
    FGD
    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
    FGD Catheter, Retention, Barium Enema With Bag

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