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510(k) Data Aggregation

    K Number
    K230439
    Device Name
    WellCare Anoscope
    Manufacturer
    Well Care (Wuhan) Medical Technology Co., Ltd
    Date Cleared
    2023-12-22

    (304 days)

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

    Well Care (Wuhan) Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
    Device Description
    WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.
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