BEUDAMED
    Product Code: HFL FDA class 2 21 CFR 884.3200

    Drain, Cervical

    Obstetrics/Gynecology

    The Cervical Drain is a device placed in the cervical canal to facilitate drainage of secretions or fluid from the uterus following surgery or infection, helping to maintain cervical patency and promote healing. It is classified as FDA Class 2 (moderate risk) and is subject to the 510(k) notification process under submission type 4. The product code is HFL, regulated under 21 CFR 884.3200, within the Obstetrics/Gynecology specialty. No special risk flags apply.

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

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    Basic Information

    Product Code
    HFL
    Device Class
    FDA class 2
    Regulation Number
    884.3200
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    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
    K903989 SIL-MED T-TUBE DRAIN

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.