BEUDAMED
    Product Code: HDG FDA class 1 21 CFR 884.4520

    Speculum, Vaginal, Metal, Fiberoptic

    Obstetrics/Gynecology

    The Metal Fiberoptic Vaginal Speculum is a gynecological examination instrument combining a standard metal speculum with an integrated fiberoptic light source, providing enhanced illumination of the vaginal canal and cervix during pelvic examination and minor gynecological procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDG under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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    510(k)s
    2
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    2
    Years Active
    9

    Basic Information

    Product Code
    HDG
    Device Class
    FDA class 1
    Regulation Number
    884.4520
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K864865 SPECULUM, VAGINAL, METAL FIBEROPTIC
    K771181 VAGINAL ILLUMINATOR, MODEL 78570

    FEI Numbers

    This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.