LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253139

    Validate with FDA (Live)

    Device Name
    Disposable Distal Cap
    Manufacturer
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-03-19

    (175 days)

    Product Code
    FBN
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K243388
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable Distal Cap is used with the cholangioscope and installed to the distal end of cholangioscope to keep appropriate endoscopic field of view.

    Device Description

    Disposable Distal Cap is used with the cholangioscope and installed to the distal end of cholangioscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, with 2 types, which are cylinder type and taper type. For each type, we have 1 specification, totally 2 specifications. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterile maintenance package to ensure a shelf life of 1 year.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1