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510(k) Data Aggregation

    K Number
    K240253
    Device Name
    Reach Needle
    Manufacturer
    Aerin Medical Inc.
    Date Cleared
    2024-03-21

    (51 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aerin Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.
    Device Description
    The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-qauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (≥ 22 years).
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    K Number
    K221907
    Device Name
    RhinAer® Stylus (FG1393)
    Manufacturer
    Aerin Medical Inc.
    Date Cleared
    2022-07-29

    (29 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aerin Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RhinAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
    Device Description
    The RhinAer Stylus is functionally unchanged from the predicate in design and intended use to generate and deliver bipolar RF energy to treat tissue in ENT procedures. The design of the Stylus shaft has been changed to improve physician visualization and access during the procedure. The Stylus shaft diameter has been reduced and is more malleable. The treatment tip shape has been re-designed to change its position relative to the shaft to facilitate tissue apposition. The subject and predicate devices have the same material composition. The device and packaging system has been tested and validated with shelf-life studies out to 6 months. The optional custom treatment parameters (power, temperature, time) have been removed.
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    K Number
    K192471
    Device Name
    RHIN1 Stylus
    Manufacturer
    Aerin Medical Inc.
    Date Cleared
    2019-12-20

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aerin Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RHIN I Stylus is indicated for use in otothing of the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
    Device Description
    The RHIN1 Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft, and treatment tip. The treatment tip consists of an array of bipolar electric es and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The shaft is malleable to allow the user to bend the shaft in order to more easily access the desired treatment area(s). The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable. The RHIN1 Stylus is used to treat patients experiencing chronic rhinitis. During a treatment procedure, the clinician inserts the shaft of the RHIN1 Stylus into a patient's nostril to position the treatment tip and deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, causing destruction of the unwanted soft tissue. The shaft of the RHIN1 Stylus is then removed from the nostril.
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