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510(k) Data Aggregation

    K Number
    K082995
    Device Name
    SMART DILATOR
    Manufacturer
    SAFESTITCH MEDICAL
    Date Cleared
    2009-02-06

    (121 days)

    Product Code
    KNQ
    Regulation Number
    876.5365
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFESTITCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMART Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization in adults 18 years or older.
    Device Description
    The SMART Dilator is a sterile, single use disposable esophageal dilator. The SafeStitch endoscope guide dilator consists of a graduated tube with a center endoscope channel, a tapered tip and a safety handle. The flexible endoscope has a relative rigidity and in combination with the dilator will provide sufficient axial integrity for dilation. The handle provides feedback to indicate how much axial force is being placed on the device and subsequently, the esophagus.
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