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510(k) Data Aggregation

    K Number
    K253403

    Validate with FDA (Live)

    Device Name
    FemVue® Controlled Saline-Air Device (FSA-300)
    Manufacturer
    Femasys, Inc.
    Date Cleared
    2025-12-15

    (76 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K110288,K242002,K241693
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K110288, K242002

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

    Device Description

    The FemVue® Controlled Saline-Air Device is a sterile dual-barrel contrast media syringe that is connected to an intrauterine catheter to instill saline-air contrast medium as part of a sono-hysterosalpingogram (Sono-HSG) procedure. Ultrasound of the fallopian tubes can be performed with or without assessment of the uterine cavity.

    The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via ethylene oxide (EO) sterilization and is intended for single-use.

    AI/ML Overview

    N/A

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