BEUDAMED
    Product Code: FGF FDA class 2 21 CFR 876.5130

    Catheter, Ureteral Disposable (X-Ray)

    Gastroenterology, Urology

    The Disposable Ureteral Catheter for X-Ray is a radiopaque single-use catheter inserted into the ureter during cystoscopy to facilitate radiological contrast studies of the upper urinary tract. 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 FGF, regulated under 21 CFR 876.5130, within the Gastroenterology, Urology specialty.

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

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    Basic Information

    Product Code
    FGF
    Device Class
    FDA class 2
    Regulation Number
    876.5130
    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
    K903994 URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION