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510(k) Data Aggregation

    K Number
    K173855
    Device Name
    Sharpsite AC Rigid Endsocope
    Manufacturer
    Medtronic Xomed Inc.
    Date Cleared
    2018-04-20

    (121 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic Xomed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures. including thinology and endoscopic plastic and reconstructive surgery. Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.
    Device Description
    The Sharpsite™ AC endoscopes are rigid rod lens endoscopes for imaging and are available in diameters from 2.7 mm to 4.0 mm and in angles of view of 0, 30, 45 and 70 degrees. These endoscopes are reusable, autoclavable instruments and are provided non-sterile. The Sharpsite™ Rigid Ear, Nose and Throat (ENT) endoscopes provide access and allow observation during otolaryngology and head and neck procedures. The device consists of rigid rod inserted into body orifice. The endoscope includes an optical system to visualize the image by direct view or with use of a camera. The endoscopes are provided non-sterile and can be reused by multiple methods as mentioned in the IFU. Each Sharpsite™ endoscope is fitted with a commercially available removable light port adapter for use with different manufacturers light cables. Sharpsite™ AC Endoscopic sterilization tray is a container which is a reusable device that includes a base and lid. It is a single level thermoplastic instrument case designed to hold Sharpsite™ AC Rigid Endoscopes. The Sharpsite™ tray is specifically configured to organize, store, protect, transport and sterilize Sharpsite™ AC Rigid Endoscopes for use in surgical procedures.
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    K Number
    K151758
    Device Name
    ALAR Nasal Valve Stent
    Manufacturer
    MEDTRONIC XOMED INC.
    Date Cleared
    2015-10-29

    (122 days)

    Product Code
    GAT, LYA
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC XOMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction. The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.
    Device Description
    The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.
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