BEUDAMED
    Product Code: FJN FDA class 2 21 CFR 876.5540

    Stabilizer, Shunt

    Gastroenterology, Urology

    The Shunt Stabilizer is a urological accessory device used to stabilize shunt tubing or connections during vascular access procedures, particularly in dialysis or urological applications. It is classified as FDA Class 2 (moderate risk), meaning it requires 510(k) premarket notification before marketing. The product code is FJN, and it is regulated under 21 CFR 876.5540, which covers urological catheters and accessories in the Gastroenterology and Urology specialty.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FJN
    Device Class
    FDA class 2
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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