BEUDAMED
    Product Code: JCQ FDA class 2 21 CFR 878.3610

    Prosthesis, Esophagus

    General, Plastic Surgery

    An esophageal prosthesis is a surgically implanted device used to replace or bypass a segment of the esophagus that has been removed or is obstructed, typically following oncological resection or treatment of severe strictures, restoring the continuity of the upper digestive tract. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JCQ, regulated under 21 CFR 878.3610, within the General and Plastic Surgery medical specialty. This device is an implant.

    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
    JCQ
    Device Class
    FDA class 2
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    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
    K896390 WILSON-COOK ESOPHAGEAL PROSTHESIS