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510(k) Data Aggregation

    K Number
    K213153
    Device Name
    SPIWay Endonasal Access Guide
    Manufacturer
    SPIWay, LLC
    Date Cleared
    2021-10-27

    (29 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIWay, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.
    Device Description
    The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.
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    K Number
    K180141
    Device Name
    SPIWay Endonasal Access Guide
    Manufacturer
    SPIWay, LLC
    Date Cleared
    2018-02-16

    (29 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIWay, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
    Device Description
    The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endoscopic sphenoid sinus and transsphenoidal surgery. The device consists of a single piece of thermoplastic polymer with a low friction coating, which creates a working channel sheath in the natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery. The shape of the SPIWay Endonasal Access Guide contains a flared portion at the proximal end of the device which remains outside the nasal passage and a conical body that sits within the nasal cavity. The flared proximal end and conical body act to anchor the device, preventing migration once inserted and allow simple removal. The device has an elliptical shape, and the major axis of the ellipse is oriented vertically with the nostril. The device is supplied in several lengths that are selected based upon the surgeon's needs. It is provided sterile and for single use in a pack of two, one for each nostril. A pair of devices is sealed in a Tyvek pouch and 5 pouches are placed into a labeled carton.
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