BEUDAMED
    Product Code: EYA FDA class 1 21 CFR 876.5130

    Stylet, Ureteral

    Gastroenterology, Urology

    The ureteral stylet is a stiffening wire or rod introduced into a ureteral catheter to provide rigidity and facilitate placement of the catheter into the ureter during diagnostic or therapeutic urological procedures. It is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is EYA, regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

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    510(k)s
    0
    FEI Numbers
    26
    Registration Numbers
    26
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EYA
    Device Class
    FDA class 1
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.