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510(k) Data Aggregation

    K Number
    K250138
    Device Name
    Small Volume 0.2mL Syringe
    Manufacturer
    Prosum Medical Limited
    Date Cleared
    2025-04-02

    (75 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
    Device Description
    The Small Volume 0.2mL Syringe is intended for manual, single use. It is a small volume 0.2 mL syringe. It is comprised of a PP barrel, ABS plunger, TPE plunger stopper, PP plunger shield and PP Luer protective cap. The device has a Luer lock connection type that enables connection to a hypodermic needle for liquid injection or withdrawal. The device has a plunger stopper to prevent any liquid residual from remaining in the syringe barrel, maximizing the efficiency of liquid usage. The feature is called Low Dead Space/Volume. The Luer protective cap serves to safeguard the small Luer connector from potential damage during transportation. Similarly, the plunger shield is utilized to ensure the small plunger remains undamaged during transportation. The Luer protective cap and the plunger shield are optional to be used. The device has been manufactured without any silicone oil. The device has six models, each equipped with a 0.2 mL Luer lock syringe. Among these models, three include an additional feature for enhanced dosing technology (EDT), which comprises a colored reference line on the plunger surface to improve visibility. These include identifying markings to distinguish the EDT models from the regular 0.2 mL syringe.
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    K Number
    K242291
    Device Name
    SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2024-11-20

    (110 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body. The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body. The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
    Device Description
    The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe. The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
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    K Number
    K232943
    Device Name
    Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
    Manufacturer
    Smiths Medical ASD Inc
    Date Cleared
    2024-05-31

    (254 days)

    Product Code
    QNQ, FMI, MEG
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
    Device Description
    The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection. The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath. The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.
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    K Number
    K241190
    Device Name
    PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2024-05-29

    (30 days)

    Product Code
    QNQ, FMI, QNS
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the skin. The device consists of a calibrated barrel (cylinder) with a plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. The distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.
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    K Number
    K231856
    Device Name
    TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
    Manufacturer
    MedExel Co., Ltd.
    Date Cleared
    2024-03-15

    (266 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
    Device Description
    The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas. The proposed device has 2 models depending on the diameter of the needle.
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    K Number
    K221860
    Device Name
    PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2023-09-15

    (445 days)

    Product Code
    QNQ, FMI, QNS
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.
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    K Number
    K213010
    Device Name
    FEELject LDV (Low dead volume) syringe
    Manufacturer
    Feeltech Co., Ltd.
    Date Cleared
    2023-05-31

    (618 days)

    Product Code
    QNQ, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
    Device Description
    A Disposable Syringe with Needle is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
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    K Number
    K213013
    Device Name
    Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
    Manufacturer
    Jeil Tech Co., Ltd.
    Date Cleared
    2022-09-19

    (364 days)

    Product Code
    QNQ, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    A Disposable Syringe with Needle is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
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    K Number
    K220083
    Device Name
    LDV((Low Dead Volume )Syringe
    Manufacturer
    Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
    Date Cleared
    2022-05-25

    (135 days)

    Product Code
    QNQ, QNS
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
    Device Description
    The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space. The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.
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    K Number
    K210443
    Device Name
    PLPT LDV (Low Dead Volume) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2021-02-16

    (0 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
    Device Description
    A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a Luer-lock connector for the attachment to a hypodermic needle or an administration set. This is a single-use device. The PLPT LDV (Low Dead Volume) Sterile Syringe is designed to reduce the fluid waste because of its plunger design.
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