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510(k) Data Aggregation

    K Number
    K153686
    Device Name
    SPIWay Endonasal Access Guide
    Manufacturer
    SPIWAY LLC
    Date Cleared
    2016-01-28

    (36 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 sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal 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
    K132721
    Device Name
    SPIWAY ENDONASAL ACCESS GUIDE
    Manufacturer
    SPIWAY LLC
    Date Cleared
    2014-01-29

    (152 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 sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of medical-grade thermoplastic elastomer.
    Ask a Question

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