Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250700
    Manufacturer
    Date Cleared
    2025-11-21

    (259 days)

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

    The Pen Injector Needle 32.5 is indicated for use with a pen injector device for patients who require the subcutaneous injection of drugs including insulin and human growth hormone as a therapy.

    Device Description

    The Pen Injector Needle 32.5 consists of a cannula, needle hub, inner needle cap, outer needle case and seal film. The outer needle case and seal film function as the primary packaging and maintain the sterility when unopened.

    The Pen Injector Needle 32.5 is a manually operated, disposable device intended for single use only. The device is individually packaged and sterilized by electron beam. The primary package consists of an outer needle case and sealing film.

    The cannula is made of stainless steel and it is Thin Walled. The cannula remains 32.5G throughout the needle length, as a straight hypodermic needle. The cannula is pointed at both the patient interface end, for injection into the patient's body tissue, and the cartridge interface end, to puncture the cartridge for drug delivery.

    The Pen Injector Needle 32.5 is available in different needle lengths. The length of the needle patient side (from the glue mount on the hub to the tip of the patient interface end) ranges from 4 mm (5/32") to 8 mm (5/16"). The patient interface end (needle tip) features a 3-bevel, asymmetrical needle edge.

    The cartridge interface end is attached to a plastic hub (needle hub) which screws onto a compatible pen injector (not supplied with this device). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1