BEUDAMED
    Product Code: NGU FDA class 2 21 CFR 876.5980

    Balloon, Liver Tamponade

    Gastroenterology, Urology

    The Balloon, Liver Tamponade (product code NGU) is a gastroenterology/urology device consisting of a balloon catheter introduced into the liver to apply tamponade pressure and control hemorrhage from hepatic trauma or post-procedural bleeding. It is classified as an FDA Class 2 device within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as a permanent implant or life-sustaining device.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NGU
    Device Class
    FDA class 2
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K010450 LIVER TAMPONADE BALLOON