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510(k) Data Aggregation

    K Number
    K221974
    Device Name
    EpiFinder
    Manufacturer
    Omeq Medical Ltd.
    Date Cleared
    2023-04-16

    (285 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Omeq Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EpiFinder is intended for use, in between a luer Loss of resistance (LOR) syringe and an epidural needle, to verify the needle tip placement in the epidural space as a secondary indicator adjunctive to the LOR technique.
    Device Description
    The EpiFinder is intended to be used in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator, giving the practitioner a clear visual signal that the needle tip has entered the epidural space. The EpiFinder is a sterile, single-use device that is used during epidural procedures. The device works with a standard loss of resistance (LOR) syringe and an epidural needle (18G) to verify that the needle tip placement is in the epidural space in patients ages 18 or older. The EpiFinder consists of a blunt tip spring-loaded probe that is installed into a standard epidural needle, and a plastic housing that is composed of a linear actuator, a sensor, and a microcontroller that measures the probe spring's contraction. The EpiFinder is attached to a Tuohy needle that has been inserted into the patient. The device has built in "wings" to help advance the needle, if the practitioner wishes to use them. As the needle advances forward, there are LED indicator lights on the housing that give feedback to the operator as to when the epidural space is entered, as input to the user in conjunction with the standard LOR technique.
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