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510(k) Data Aggregation

    K Number
    K233056
    Device Name
    EpiZact
    Date Cleared
    2023-11-02

    (38 days)

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

    GuideStar Medical Devices

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EpiZact is intended for use with an epidural needing a loss of resistance, which ads a clinician in verifying needle tip placement in the epidural space.
    Device Description
    EpiZact is a self-pressurizing piston syringe that uses the same loss of resistance technique used by physicians to detect the epidural space. The device is single use, sterile, hanually powered, and designed to connect to standard epidural Tuohy needles (16-18 gauge) with a standard Luer connector. EpiZact provides tactile feedback, in addition to visual feedback, when a loss of resistance is detected. The tactile feedback is also designed to help reduce the forward motion of the needle upon detection of loss of resistance. The device is comprised of copolyester plastic, stainless steel springs, silicone Orings, silicone and ABS valve, and polydimethylsiloxane (silicone) lubricant.
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