BEUDAMED
    Product Code: QNS FDA class 2 21 CFR 880.5570

    Low Dead Space Needle, Single Lumen, Hypodermic

    General Hospital

    The Low Dead Space Needle (Single Lumen, Hypodermic) is a device designed to reduce medication waste, consisting of a metal tube sharpened at one end and joined at the other to a connector for mating with a piston syringe. It may include needle safety features and can be used by healthcare professionals or for patient self-injection. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5570 in the General Hospital specialty. It carries product code QNS and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    3
    Years Active
    4

    Basic Information

    Product Code
    QNS
    Device Class
    FDA class 2
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
    K231734 STERiJECT Low Dead Space, STERiJECT The Invisible Needle
    K210444 EZ-Injec LDV Sterile Safety Needle

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.