BEUDAMED
    Product Code: FHL FDA class 1 21 CFR 876.4730

    Scoop

    Gastroenterology, Urology

    The Scoop is a spoon-shaped surgical instrument used in gastrointestinal or urological procedures to remove, collect, or manipulate tissue, calculi, or other material from a body cavity. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls. The product code is FHL, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    64
    Registration Numbers
    64
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FHL
    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 64 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.