BEUDAMED
    Product Code: FHK FDA class 1 21 CFR 876.4730

    Spreader, Bladder Neck

    Gastroenterology, Urology

    The Bladder Neck Spreader is a surgical instrument used to dilate or spread the bladder neck region during urological procedures, facilitating access and visualization. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. The product code is FHK, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

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    510(k)s
    0
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    FHK
    Device Class
    FDA class 1
    Regulation Number
    876.4730
    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 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.