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510(k) Data Aggregation

    K Number
    K160644
    Device Name
    Lelo Hex Natural Rubber Latex Condom
    Manufacturer
    LELO Inc.
    Date Cleared
    2016-06-30

    (115 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device: the Lelo Hex Natural Rubber Latex Condom. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

    Therefore, I cannot provide the requested information based on the provided text.

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