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510(k) Data Aggregation

    K Number
    K240114
    Device Name
    UltraEzAir® (UEA1A)
    Manufacturer
    DUALAMS, Inc., dba AirKor
    Date Cleared
    2024-10-16

    (274 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures. The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
    Device Description
    The UltraEzAir® is a prescription medical device intended for application of nebulized 4% topical lidocaine solution to the oropharynx and upper airway region of patients. The subject device is an electrically driven device. The subject device is intended to be used only in an outpatient clinical facility or office for anesthetic procedures by a healthcare professional who is trained by Airkor® on its use. The UltraEzAir® is intended to be used on adult patients, weighing at least 80 lbs. requiring topical anesthesia of oropharynx and upper airway region prior to endoscopic examination in an outpatient clinical facility or office. The UltraEzAir® consists of a reusable Base, a single-use non-sterile Mist Assembly placed on the Base, and a single-use nonsterile Delivery Line connected to the Mist Assembly. The Delivery Line is then connected to the working channel of an Olympus or Pentax flexible nasal laryngoscope and the lidocaine mist is applied using the distal end of the attached laryngoscope to adjacent target tissue. The application process is visualized using the attached laryngoscope.
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    K Number
    K172956
    Device Name
    Medicant Mucosal Atomizer
    Manufacturer
    Medica Holdings, LLC
    Date Cleared
    2018-04-06

    (192 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.
    Device Description
    The proposed device delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration of the device is placed inside an endotracheal tube for a directed spray. The device is offered in 3 configurations, all supplied with a 3 cc syringe.
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    K Number
    K153470
    Device Name
    MADgic Laryngo-Tracheal Mucosal Atomization Device
    Manufacturer
    TELEFLEX MEDICAL
    Date Cleared
    2016-08-19

    (261 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
    Device Description
    The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.
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    K Number
    K093584
    Device Name
    EZ-MISTER
    Manufacturer
    N.M. BEALE CO. INC.
    Date Cleared
    2011-03-04

    (470 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
    Device Description
    The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.
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    K Number
    K070596
    Device Name
    TOPICAL APPLICATOR
    Manufacturer
    SHARN, INC.
    Date Cleared
    2007-06-21

    (111 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for atomizing topical anesthetics to the oropharynx and upper airway regions
    Device Description
    The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions.
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    K Number
    K002255
    Device Name
    LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
    Manufacturer
    WOLFE TORY MEDICAL, INC.
    Date Cleared
    2000-09-18

    (55 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Product Code :

    CCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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