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

    FemVue MINI Saline-Air Device

    K Number: K242002 · Decision Nov 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    136

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    Basic Information

    Device Name
    FemVue MINI Saline-Air Device
    K Number
    K242002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Femasys, Inc.
    Date Received
    July 9, 2024
    Decision Date
    November 22, 2024
    Product Code
    LKF
    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
    LKF Cannula, Manipulator/Injector, Uterine

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    Other Clearances by Femasys, Inc.

    K Number Device Name
    K253403 FemVue® Controlled Saline-Air Device (FSA-300)
    K241693 FemChec Controlled Saline-Air Device (FCD-250)
    K231730 FemaSeed Intratubal Insemination
    K122658 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
    K110993 FEMCHEC PRESSURE MANAGEMET DEVICE
    K110288 FEMVUE SALINE-AIR DEVICE
    K100662 FEMVUE CORNUAL BALLOON CATHETER
    K083690 FEMVUE(TM) CATHETER SYSTEM