BEUDAMED
    Product Code: FEZ FDA class 2 21 CFR 876.5090

    Catheter And Tube, Suprapubic

    Gastroenterology, Urology

    The Suprapubic Catheter and Tube is a urological device inserted through the abdominal wall directly into the urinary bladder above the pubic bone to provide urinary drainage when urethral catheterization is not possible or appropriate. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FEZ, regulated under 21 CFR 876.5090, within the Gastroenterology, Urology specialty. This device is intended for implantation.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FEZ
    Device Class
    FDA class 2
    Regulation Number
    876.5090
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K771066 CATHETER, SAMPLING, CONDUIT

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.