BEUDAMED
    Product Code: HFA 21 CFR 884.1600

    Amnioscope, Transabdominal (Fetoscope) (And Accessories)

    Obstetrics/Gynecology

    The Transabdominal Amnioscope (Fetoscope and accessories) is an endoscopic device introduced through the abdominal wall to allow direct visualization of the fetus and placenta in utero, used for diagnostic procedures such as fetal blood sampling or structural assessment. This device has an unclassified or pre-amendment status (device class "f"), meaning it has not been assigned a standard Class 1, 2, or 3 classification and may be subject to a separate regulatory pathway. The product code is HFA, regulated under 21 CFR 884.1600, within the Obstetrics/Gynecology specialty. No implant or life-sustaining flags apply.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HFA
    Regulation Number
    884.1600
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    6

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.