BEUDAMED
    Product Code: ONJ FDA class 2 21 CFR 876.4680

    Dissolvable Gel For Preventing Ureteral Stone Migration

    Gastroenterology, Urology

    The Dissolvable Gel For Preventing Ureteral Stone Migration (product code ONJ) is a Class 1 device regulated under 21 CFR 876.4680 in the Gastroenterology, Urology specialty (GU), exempt from premarket notification. It is used within the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures, serving as a temporary barrier to keep stones in position. The device is not an implant and is not life-sustaining.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    ONJ
    Device Class
    FDA class 2
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    Definition

    For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.

    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
    K090430 BACKSTOP AND BACKSTOP INJECTOR

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.