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

    Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

    K Number: K251170 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    150

    Basic Information

    Device Name
    Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
    K Number
    K251170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tangent Endoscopy, LLC
    Date Received
    April 15, 2025
    Decision Date
    September 12, 2025
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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