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510(k) Data Aggregation

    K Number
    K231255
    Device Name
    NovoFine® Plus
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2023-08-25

    (116 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
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    K Number
    K210258
    Device Name
    NovoFine
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2021-06-23

    (142 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
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    K Number
    K202005
    Device Name
    NovoFine Plus 32G Tip x 4 mm
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2020-12-19

    (151 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: NovoFine® Plus 32 G 4 mm needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    NovoFine® Plus 32 G 4 mm needle is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
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    K Number
    K182387
    Device Name
    NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2018-12-17

    (104 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
    Device Description
    The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.
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    K Number
    K173479
    Device Name
    NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2018-01-17

    (65 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.
    Device Description
    NovoFine® 32 G Tip (0.23/0.25) 6 mm ETW needle is designed for single use. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
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    K Number
    K162602
    Device Name
    NovoPen Echo
    Manufacturer
    Novo Nordisk Inc.
    Date Cleared
    2016-10-18

    (29 days)

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

    Novo Nordisk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the seff-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
    Device Description
    The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.
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    K Number
    K150874
    Device Name
    NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
    Manufacturer
    NOVO NORDISK INC.
    Date Cleared
    2015-07-31

    (121 days)

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

    NOVO NORDISK INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) finsulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
    Device Description
    The NovoPen Echo® (STJ) is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] . The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injector for the injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected. The pen-injector is intended for use with PenFill® 3 mL cartridge of NovoLog", 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] and a single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk ).
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    K Number
    K133738
    Device Name
    NOVOFINE PLUS 32G 4 MM
    Manufacturer
    NOVO NORDISK INC.
    Date Cleared
    2014-05-21

    (163 days)

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

    NOVO NORDISK INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
    Device Description
    NovoFine® Plus needles are single use, sterile need in conjunction with pen injector devices. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used.
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    K Number
    K123766
    Device Name
    NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
    Manufacturer
    NOVO NORDISK INC.
    Date Cleared
    2013-08-15

    (251 days)

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

    NOVO NORDISK INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovoPen Echo* is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses Penli ill " 3 mL cartridges of Novo Nordisk insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
    Device Description
    The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in half unit increments, from a Novo Nordisk 3.0 mL insulin cartridge. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected. The pen-injector is intended for use with Novo Nordisk 3.0 mL insulin cartridges and single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk).
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    K Number
    K093109
    Device Name
    NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
    Manufacturer
    NOVO NORDISK INC.
    Date Cleared
    2010-06-18

    (260 days)

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

    NOVO NORDISK INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.
    Device Description
    NovoTwist® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices built with bayonet coupling. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then pressed onto the injection delivery device with a bayonet coupling and twisted a quarter of a revolution until tightness and a confirmatory click is heard. Then the outer and inner caps of the needle are removed. Injection is performed by following the procedure described in the User Manual provided with the pen injection device and instructions from your health care professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap. The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.
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