BEUDAMED
    Product Code: MLT FDA class 2 21 CFR 884.4530

    Pelvic Exam Kit

    Obstetrics/Gynecology

    The Pelvic Exam Kit is a pre-assembled set of sterile supplies used by clinicians to conduct gynecological pelvic examinations, including components such as specula, swabs, and specimen collection materials, established under FDA guidance from May 20, 1997. Classified as a Class 2 device under 21 CFR 884.4530 within the Obstetrics and Gynecology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MLT
    Device Class
    FDA class 2
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

    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
    K931822 CARAPACE PELVIC EXAM TRAYS

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.