BEUDAMED
    Product Code: LTI FDA class 3

    Implant, Intragastric For Morbid Obesity

    Unknown

    The Intragastric Implant for Morbid Obesity is a device surgically or endoscopically placed within the stomach to occupy space and reduce the effective gastric volume, thereby promoting satiety and limiting food intake as a treatment for morbid obesity. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) due to the risks of gastric injury, obstruction, and other serious complications associated with long-term intragastric placement. The product code is LTI; no regulation number or specific medical specialty code is on file. This device carries the implant flag, as it is placed within the body for an extended period.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LTI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.