BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SureCore Plus Biopsy Instrument

    Reg #: 3027269340 · FEI: 3027269340 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    URO1 MEDICAL, INC.
    Registration Number
    3027269340
    FEI Number
    3027269340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3703 Alliance Drive, Suite A
    City
    Greensboro
    State
    NC
    ZIP
    27407
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220611

    Owner / Operator

    Firm Name
    Uro1 Medical, Inc.
    Operator Number
    10087857
    Address
    3703 Alliance Drive, Suite A
    City
    Greensboro
    State
    NC
    Postal Code
    27407
    Country
    US
    Correspondent
    Thomas Lawson

    Products

    Device Name Product Code
    Instrument, Biopsy KNW

    Proprietary Names

    SureCore Plus Biopsy Instrument

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device