BEUDAMED
    Product Code: FES FDA class 2 21 CFR 876.1725

    Recorder, External, Pressure, Amplifier & Transducer

    Gastroenterology, Urology

    The External Pressure Recorder, Amplifier and Transducer is a diagnostic system used to measure and record pressure data in the gastrointestinal or urological tract, such as during urodynamic studies. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FES, regulated under 21 CFR 876.1725, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    9

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    Basic Information

    Product Code
    FES
    Device Class
    FDA class 2
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K890284 URODEC 500
    K801757 MMI/GAELTEC CATHETER TIP PRESS. TRANSDU