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

    TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)

    K Number: K123659 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    10
    Review Days
    22

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    Basic Information

    Device Name
    TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
    K Number
    K123659
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Actuated Medical, Inc.
    Date Received
    November 28, 2012
    Decision Date
    December 20, 2012
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Actuated Medical, Inc.

    K Number Device Name
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    K231254 GripTract-GI Endoscopic Tissue Manipulator
    K220890 IO Needle Safety Sheath
    K200646 TubeClear System
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    K131052 TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
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