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510(k) Data Aggregation

    K Number
    K230287
    Device Name
    SaviSafe Safety Device
    Manufacturer
    Suzhou Savicred Biotechnology Co., Ltd.
    Date Cleared
    2023-11-21

    (292 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
    Device Description
    The proposed device, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2". The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.
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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?
    Product Code :

    MEG

    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
    K231907
    Device Name
    Medline Safety Insulin and TB Syringes
    Manufacturer
    Medline Industries, LP
    Date Cleared
    2023-10-18

    (111 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks. The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
    Device Description
    The Medline Safety Insulin Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for delivery of U-100 Insulin. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver insulin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense insulin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The Medline Safety Insulin Syringe barrel contains major and minor graduated ink markings and will be available in a 1 ml (100 units), and 0.5 ml (50 units) syringe volumes with three different needle gauge sizes. The Medline TB Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for Tuberculin use. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver tuberculin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense tuberculin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The syringe barrel contains graduated markings, with major graduation markings every 0.05mL and minor graduation markings every 0.01mL. The Medline TB Syringe will be available in a 1 mL syringe volume with three different needle sizes.
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    K Number
    K223376
    Device Name
    Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
    Manufacturer
    Cardinal Health 200, LLC
    Date Cleared
    2023-06-21

    (229 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
    Device Description
    The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.
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    K Number
    K220114
    Device Name
    PowerPAK Syringe
    Manufacturer
    Vault Paragon Group, Inc.
    Date Cleared
    2023-01-25

    (376 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device. The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device. The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.
    Device Description
    The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device. The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers. The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.
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    K Number
    K221981
    Device Name
    SafeR Syringe and SafeR Sting
    Manufacturer
    Roncadelle Operations srl
    Date Cleared
    2022-12-29

    (177 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.
    Device Description
    SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use.
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    K Number
    K222452
    Device Name
    Disposable Automatically Retractable Safety Syringes (with detachable needle)
    Manufacturer
    Shantou Wealy Medical Instrument CO.,Ltd.
    Date Cleared
    2022-11-23

    (100 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
    Device Description
    The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.
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    K Number
    K221247
    Device Name
    Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd.
    Date Cleared
    2022-11-01

    (183 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
    Device Description
    The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle. Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size. Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle. The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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    K Number
    K220057
    Device Name
    Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
    Manufacturer
    Shinva Ande Healthcare Apparatus Co., Ltd.
    Date Cleared
    2022-10-07

    (274 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto-disable Syringe for Fixed-dose Immunization is intended for use in the aspiration and injection of fluids for medical purpose.
    Device Description
    Not Found
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    K Number
    K221073
    Device Name
    Sterile Hypodermic Syringes for Single Use with Safety Needles
    Manufacturer
    Sichuan Prius Biotechnology Co., Ltd.
    Date Cleared
    2022-10-04

    (175 days)

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

    MEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
    Device Description
    The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
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