BEUDAMED
    Product Code: LBX FDA class 2 21 CFR 884.4530

    Pelvimeter, Internal

    Obstetrics/Gynecology

    An internal pelvimeter is an obstetric instrument used to measure the internal dimensions of the bony pelvis during physical examination, assisting in assessment of pelvic adequacy for vaginal delivery. It is classified as FDA Class 2, indicating moderate risk and the need for 510(k) premarket notification. The product code is LBX, regulated under 21 CFR 884.4530, in the Obstetrics/Gynecology specialty. Third-party review eligibility applies.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LBX
    Device Class
    FDA class 2
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    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
    K834173 OP-CON SURGICAL INSTRUMENTS #4