BEUDAMED
    Product Code: HDH FDA class 1 21 CFR 884.4530

    Needle, Cerclage, Gynecological

    Obstetrics/Gynecology

    The Gynecological Cerclage Needle is a specialized surgical needle used to place cerclage sutures around the cervix in patients with cervical insufficiency to prevent premature dilation and reduce the risk of second-trimester pregnancy loss or preterm birth. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDH under regulation 21 CFR 884.4530 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HDH
    Device Class
    FDA class 1
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    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 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.