BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    UniPearls® Embolic Microspheres

    K Number: K231554 · Decision Nov 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    168

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UniPearls® Embolic Microspheres
    K Number
    K231554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Haowei Medical Technology Co., Ltd.
    Date Received
    May 30, 2023
    Decision Date
    November 14, 2023
    Product Code
    KRD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KRD), ordered by most recent decision date.

    HARBOR Occlusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOBO Vascular Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Concerto Versa™ Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tembo Embolic System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OBSIDIO™ Conformable Embolic (M0013972101010)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Polyvinyl Alcohol Embolic Microspheres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all