BEUDAMED
    Product Code: KPH FDA class 1 21 CFR 876.5030

    Catheter, Rectal For Continent Ileostomy

    Gastroenterology, Urology

    This device is a rectal catheter designed for use in continent ileostomy procedures, enabling patients to drain an internal pouch created from the small intestine following colectomy. It is classified as FDA Class 1, the lowest risk category, regulated by general controls only. The product code is KPH, regulated under 21 CFR 876.5030 within the Gastroenterology and Urology specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KPH
    Device Class
    FDA class 1
    Regulation Number
    876.5030
    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
    K813494 WATERS ILEAL RESERVOIR CATHETER

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.