BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Fetal Pillow

    K Number: K243799 · Decision Aug 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    41
    Review Days
    261

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    Basic Information

    Device Name
    Fetal Pillow
    K Number
    K243799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4350
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CooperSurgical, Inc.
    Date Received
    December 11, 2024
    Decision Date
    August 29, 2025
    Product Code
    PWB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PWB Fetal Head Elevator

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