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

    GripTract-GI Endoscopic Tissue Manipulator Lower GI Models

    K Number: K242325 · Decision Oct 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    10
    Review Days
    59

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    Basic Information

    Device Name
    GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
    K Number
    K242325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Actuated Medical, Inc.
    Date Received
    August 6, 2024
    Decision Date
    October 4, 2024
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by Actuated Medical, Inc.

    K Number Device Name
    K251041 GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
    K231254 GripTract-GI Endoscopic Tissue Manipulator
    K220890 IO Needle Safety Sheath
    K200646 TubeClear System
    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