BEUDAMED
    Product Code: PON FDA class 2 21 CFR 884.4260

    Catheter, Balloon, Dilation Of Cervical Canal

    Obstetrics/Gynecology

    The Catheter, Balloon, Dilation Of Cervical Canal (product code PON) is a Class 2 obstetrics and gynecology device intended for mechanical dilation and softening of the cervix, regulated under 884.4260. It requires 510(k) clearance and falls within the obstetrics and gynecology medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    5

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    Basic Information

    Product Code
    PON
    Device Class
    FDA class 2
    Regulation Number
    884.4260
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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

    Definition

    Mechanical dilation and softening of the cervix.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K202433 Aqueduct 200 Cervical Dilation Balloon Catheter
    K202427 Aqueduct 100 Plus Cervical Dilation Balloon Catheter
    K190813 CrossBay Cervical Dilator Catheter System
    K160664 Aqueduct 100 Cervical Dilator