BEUDAMED
    Product Code: FHR FDA class 1 21 CFR 878.4800

    Needle, Gastro-Urology

    General, Plastic Surgery

    The Gastro-Urology Needle is a surgical needle used for suturing during gastrointestinal or urological operations, typically as part of an anastomosis or tissue repair. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls. The product code is FHR, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FHR
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    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
    K811965 VISITEC NEEDLE RANGE (GASTERUROLOGY)

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.