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510(k) Data Aggregation

    K Number
    K251692

    Validate with FDA (Live)

    Device Name
    Advanced Tissue Resection Device
    Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-02-21

    (264 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Advanced Tissue Resection Device has been designed to be used with an endoscope to electrosurgically resect mucosa within the digestive tract.

    Device Description

    Not Found

    AI/ML Overview

    N/A

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