BEUDAMED
    Product Code: EXN FDA class 1 21 CFR 876.5970

    Support, Hernia

    Gastroenterology, Urology

    The hernia support is an external bracing or truss device worn to apply pressure over an inguinal, femoral, or other hernia, helping to hold the hernia in place and reduce symptoms in patients who are not surgical candidates or awaiting surgery. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EXN, regulated under 21 CFR 876.5970 in the Gastroenterology, Urology specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    EXN
    Device Class
    FDA class 1
    Regulation Number
    876.5970
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    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
    K901922 SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536

    FEI Numbers

    This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.