BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Edison System

    Reg #: 3027664504 · FEI: 3027664504 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HISTOSONICS, INC
    Registration Number
    3027664504
    FEI Number
    3027664504
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16305 36th Avenue North, Suite 300
    City
    Plymouth
    State
    MN
    ZIP
    55446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233466

    Owner / Operator

    Firm Name
    HistoSonics, Inc
    Operator Number
    10088809
    Address
    16305 36th Avenue North, Suite 300
    City
    Plymouth
    State
    MN
    Postal Code
    55446
    Country
    US
    Correspondent
    Daniel A Kosednar

    Products

    Device Name Product Code
    Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation QGM

    Proprietary Names

    Edison System

    Establishment Types

    Manufacture Medical Device