BEUDAMED
    Product Code: MFJ FDA class 2 21 CFR 876.1500

    Device, Endoscopic Suturing

    Gastroenterology, Urology

    The endoscopic suturing device is a gastroenterology/urology device used during endoscopic procedures to place sutures within the gastrointestinal tract, enabling tissue approximation, defect closure, or fixation of implants such as anti-reflux devices. It is classified as FDA Class II under 21 CFR 876.1500 within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. The product code is MFJ and the device is not implanted. Full GMP quality system requirements apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MFJ
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K905722 SUTURE APPLIER DEVICE