BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sonablate

    Reg #: 2951226 · FEI: 3002132857 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Focus Surgery, Inc.
    Registration Number
    2951226
    FEI Number
    3002132857
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4000 Pendleton Way
    City
    Indianapolis
    State
    IN
    ZIP
    46226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160942

    Owner / Operator

    Firm Name
    Sonablate Corp. (FKA) SonaCare Medical, LLC
    Operator Number
    10040576
    Address
    10130 Perimeter Parkway, Suite 410
    City
    Charlotte
    State
    NC
    Postal Code
    28216
    Country
    US
    Correspondent
    Justin Fortner

    Products

    Device Name Product Code
    High Intensity Ultrasound System For Prostate Tissue Ablation PLP

    Proprietary Names

    Sonablate

    Establishment Types

    Manufacture Medical Device