BEUDAMED
    Product Code: NVT FDA class 1 21 CFR 884.1700

    Tubing And Tubing/Filter Fits

    Obstetrics/Gynecology

    The Hysteroscopy Tubing and Tubing/Filter Fits are devices used during hysteroscopy procedures to distend the uterine cavity by filling it with liquid or gas, facilitating visualization with a hysteroscope. These accessories are essential components supporting uterine distension media delivery during diagnostic and operative hysteroscopy. It is an FDA Class 1 device regulated under 21 CFR 884.1700 in the Obstetrics/Gynecology specialty, with product code NVT, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.

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    510(k)s
    0
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NVT
    Device Class
    FDA class 1
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    Definition

    Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.