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

    Lap-Band System Calibration Tube

    K Number: K220455 · Decision Jun 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    110

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    Basic Information

    Device Name
    Lap-Band System Calibration Tube
    K Number
    K220455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reshape Lifesciences
    Date Received
    February 17, 2022
    Decision Date
    June 7, 2022
    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 Reshape Lifesciences

    K Number Device Name
    K241039 ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
    K230131 ReShape Calibration Tubes
    K221898 Gastrointestinal Boundary Identifier (GIBI HD)