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

    TubeClear System

    K Number: K200646 · Decision Dec 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    10
    Review Days
    267

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    Basic Information

    Device Name
    TubeClear System
    K Number
    K200646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Actuated Medical, Inc.
    Date Received
    March 12, 2020
    Decision Date
    December 4, 2020
    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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    K242325 GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
    K231254 GripTract-GI Endoscopic Tissue Manipulator
    K220890 IO Needle Safety Sheath
    K172556 TubeClear System
    K163092 TubeClear Control Box and Clearing Stem
    K131052 TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
    K123659 TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
    K121571 TUBECLEAR