BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CT-STOR

    K Number: K201789 · Decision Sep 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    447

    Basic Information

    Device Name
    CT-STOR
    K Number
    K201789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5885
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Energy Delivery Solutions
    Date Received
    June 30, 2020
    Decision Date
    September 20, 2021
    Product Code
    NDS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NDS Media, Culture, Ex Vivo, Tissue And Cell

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