BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UROLOGIX, LLC

    Reg #: 2133936 · FEI: 3000718675 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    UROLOGIX, LLC
    Registration Number
    2133936
    FEI Number
    3000718675
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13355 10th Ave N., Suite 110
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113380
    PMA Number
    P970008

    Owner / Operator

    Firm Name
    Urologix LLC
    Operator Number
    10051240
    Address
    13355 10th Ave N., Suite 110
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US
    Correspondent
    Mark Swanson

    Products

    Device Name Product Code
    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy MEQ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Coolwave Targis Electrosurgical, Cutting & Coagulation & Accessories - Prostiva; Electrosurgical, Cutting & Coagulation & Accessories -

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device