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510(k) Data Aggregation

    K Number
    K252908

    Validate with FDA (Live)

    Date Cleared
    2026-03-25

    (194 days)

    Product Code
    Regulation Number
    880.5570
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

    Device Description

    Easydrip Pen Needles are single-use, sterile, and non-pyrogenic medical device designed to be used with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. The subject devices include four models, i.e. Easydrip Classic, Easydrip Classic Pro, Easydrip Plus, and Easydrip Plus Pro. All models have the same operation methods and similar materials. The device comprises a stainless needle, needle hub, inner cap, outer cap and sealing paper, and the needle surface coated with silicone oil. The needle hub of the device can be screwed onto compatible pen injector devices.

    AI/ML Overview

    N/A

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