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510(k) Data Aggregation

    K Number
    K250853

    Validate with FDA (Live)

    Device Name
    Merit Syringe
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2025-11-04

    (228 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K173601
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.

    Device Description

    The Merit Syringe a standard three-piece piston syringe intended for general purpose injection and aspiration by a qualified clinician. The syringe is constructed of a calibrated, hollow, clear polycarbonate barrel into which is inserted a closely fitted movable ABS plunger with black silicone rubber piston seal (tip). The barrel is marked with standard graduations per ISO 7886-1 requirements and contains an ISO 80369-7 compliant fixed male luer, small-bore connector. The subject device is single use and is available in either an ethylene oxide (EO) or gamma-sterile configuration.

    AI/ML Overview

    N/A

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