BEUDAMED
    Product Code: FHB FDA class 1 21 CFR 876.4730

    Hook, Gastro-Urology

    Gastroenterology, Urology

    The Gastro-Urology Hook is a manual surgical instrument with a curved hook tip used to manipulate, retract, or dissect tissue during gastrointestinal or urological surgical procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is FHB, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

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    510(k)s
    0
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FHB
    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 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.