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510(k) Data Aggregation

    K Number
    K252005

    Validate with FDA (Live)

    Device Name
    Livi Device
    Manufacturer
    Liviwell, Inc.
    Date Cleared
    2026-03-20

    (266 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K241064
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Livi device is intended for insertion into the vagina following sexual intercourse for the absorption of semen or other vaginal discharge. The device does not prevent pregnancy or protect against sexually transmitted infections (STIs).

    Device Description

    The Livi device is an over the counter (OTC), single-use, non-sterile fluid absorptive device designed for insertion into the vagina for the absorption of semen or other vaginal discharge. The Livi device is intended to be worn for up to 15 minutes, and is not intended as a contraceptive, proceptive, or for use to absorb menstrual fluid during menstruation.

    AI/ML Overview

    N/A

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