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510(k) Data Aggregation

    K Number
    K250658
    Device Name
    SureFine Pen Needle
    Manufacturer
    SHINA MED CORPORATION
    Date Cleared
    2025-04-03

    (29 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA MED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
    Device Description
    SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container. The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
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    K Number
    K231165
    Device Name
    Shina Syringe; Shina Safety Syringe
    Manufacturer
    Shina Med Corporation
    Date Cleared
    2023-10-27

    (185 days)

    Product Code
    MEG, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shina Med Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle 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. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
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    K Number
    K210848
    Device Name
    Sure-Fine Insulin Syringes
    Manufacturer
    Shina Med Corporation
    Date Cleared
    2022-03-01

    (344 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shina Med Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
    Device Description
    Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.
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    K Number
    K191531
    Device Name
    Sure-Fine Insulin Syringes
    Manufacturer
    Shina Med Corporation
    Date Cleared
    2019-09-06

    (88 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shina Med Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
    Device Description
    Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.
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    K Number
    K152879
    Device Name
    Sure-Fine Insulin Syringes
    Manufacturer
    SHINA MED CORPORATION
    Date Cleared
    2016-09-09

    (345 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA MED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
    Device Description
    Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. Category: U-100 Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge Needle Length: 1/2", 5/16" Cap color: Needle cap: Orange, Plunger Cap: Orange or white This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.
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    K Number
    K152877
    Device Name
    SureFine Pen Needle
    Manufacturer
    SHINA MED CORPORATION
    Date Cleared
    2016-06-07

    (251 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA MED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
    Device Description
    The SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and the needle tube with blister paper sealed on the opening hole of primary container. The needle hub can be connected with the pen. The hub has internal threads, which allows it to be screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. The SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization) and non-pyrogenic. The pen needles are disposable, single use devices.
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