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510(k) Data Aggregation

    K Number
    K252886

    Validate with FDA (Live)

    Device Name
    Pen Needle
    Manufacturer
    Hh Global Technology, Inc.
    Date Cleared
    2026-01-06

    (118 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    18 - 999
    Reference & Predicate Devices
    K230635,K220129
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K230635

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.

    Device Description

    The Pen Needle is a sterile, single use device intended for use with pen injector devices for the subcutaneous injection of drug. The device is available in ordinary and safety configurations.

    The following are the types of needles:

    • Ordinary Type I, Ordinary Type IB, Ordinary Type VIA, Ordinary Type VIB, and Ordinary Type VIC needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, and seal paper.

    • Safety Type IIA, Safety Type IIB, and Safety Type IIIA needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, spring, and seal paper.

    • Safety Type IIIB, Safety Type VII, Safety Type VIII, and Safety Type IX needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, spring, and seal paper.

    • Safety Type IV needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear inner core, spring, and seal paper.

    • Safety Type V and Safety Type X needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, spring, rear spring and seal paper.

    • Ordinary Type XI needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, adjusting sleeve and seal paper.

    • Safety Type XII needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, adjusting sleeve, spring, rear spring and seal paper.

    The needle shield and rear needle shield provide physical protection to the needle tube before and after use. The needle container together with seal paper forms the primary sterile barrier system and protects the needle hub. The hub is designed to be securely screwed onto the needle-based injection system (e.g. pen injector) for the subcutaneous injection of drug.

    The product is individually packaged and sterilized by irradiation to achieve a sterility assurance level (SAL) of 10⁻⁶. It is intended for single use only.

    AI/ML Overview

    N/A

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