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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
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K191011
    Why did this record match?
    Device Name :

    Andorate Universal Endoscope Tip Guard

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided document describes the Andorate Universal Endoscope Tip Guard (K202838), which is intended to protect the tip of an endoscope during transport and storage. It is explicitly stated that it is not intended for use during sterilization.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance IndicatorReported Device Performance (Andorate Universal Endoscope Tip Guard)
    Protection of Endoscope TipDemonstrated in bench testing (specifically, "compression test").
    Endoscope CompatibilityDemonstrated in bench testing. Device fits 2.5mm - 14mm endoscopes.
    BiocompatibilityMet ISO 10993 standards (non-patient contact, tested for mucosal membrane contact for
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