BEUDAMED
    Product Code: NOY FDA class 2 21 CFR 876.5550

    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

    Gastroenterology, Urology

    The embolic agents for treatment of benign prostatic hyperplasia (BPH) consist of one or more objects placed permanently within prostatic blood vessels to obstruct blood flow and reduce prostate size as a treatment for BPH. This device is classified as FDA Class 2 under regulation 876.5550 in the Gastroenterology and Urology specialty, requiring 510(k) clearance, and carries an implant flag. Product code NOY is not eligible for third-party review.

    View on FDA
    510(k)s
    4
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    4
    Years Active
    4

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    Basic Information

    Product Code
    NOY
    Device Class
    FDA class 2
    Regulation Number
    876.5550
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K203276 Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
    K192684 HydroPearl Microspheres
    K180102 Embozene Color-Advanced Microspheres
    DEN160040 Embosphere Microspheres

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.