BEUDAMED
    Product Code: HDL FDA class 1 21 CFR 884.4520

    Retractor, Vaginal

    Obstetrics/Gynecology

    The Vaginal Retractor is a gynecological surgical instrument used to hold the vaginal walls apart, providing the surgeon with adequate exposure and visualization of the cervix, uterus, and vaginal tissues during pelvic examination, surgery, or gynecological procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDL under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

    View on FDA
    510(k)s
    2
    FEI Numbers
    118
    Registration Numbers
    118
    Unique Applicants
    2
    Years Active
    11

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    Basic Information

    Product Code
    HDL
    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
    K891038 VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY
    K780349 VAGINAL RETRACTOR

    FEI Numbers

    This FDA classification entry is associated with 118 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 118 registration numbers. Click on an entry to view related FDA registrations.