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510(k) Data Aggregation

    K Number
    K202838
    Device Name
    Andorate Universal Endoscope Tip Guard
    Manufacturer
    GA Health Company Limited
    Date Cleared
    2021-03-05

    (161 days)

    Product Code
    OCU, K19, PRO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.
    Device Description
    The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.
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    K Number
    K191715
    Device Name
    Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
    Manufacturer
    STERIS Corporation
    Date Cleared
    2020-01-27

    (215 days)

    Product Code
    OCU
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.
    Device Description
    The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector: - Is composed on non-porous plastic material that allows for air flow - Has minimal contact points with the endoscope or medical/surgical instruments - Fits a wide variety of devices: 4.9mm -15mm outer diameter - Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage. The Endoscope Tip Protector is available both non-sterile and sterile.
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    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?
    Product Code :

    OCU

    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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    K Number
    K030684
    Device Name
    SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
    Manufacturer
    ACMI CORPORATION
    Date Cleared
    2003-06-03

    (90 days)

    Product Code
    OCU, KCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.
    Device Description
    The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed holes along the length of the shaft. It is designed to snap onto ACMI telescopes for protection during storage and sterilization.
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