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510(k) Data Aggregation

    K Number
    K191011
    Device Name
    Scope ProTech
    Manufacturer
    Meditech Endoscopy Ltd
    Date Cleared
    2019-05-07

    (21 days)

    Product Code
    OCU
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meditech Endoscopy Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.
    Device Description
    The Scope ProTech is a single-use, sterile endoscopic tip protector which provides a simple, safe, and highly effective method of protecting the delicate optics of an endoscope, while allowing the tip to 'breath' and thus not allowing biofilm to form. The Scope ProTech is available in two models to fit a range of scopes: INOV8-028S (Scope ProTech Small) for scope sizes 2.7 to 8mm and INOV8-028L (Scope ProTech Large) for scope sizes 8.7 to 14.7mm. The Scope ProTech is manufactured using injection moulding using a soft polypropylene.
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