BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oracle EUS Balloon (00711891) (EN-CFE)

    Reg #: 1528319 · FEI: 1000122656 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    UNITED STATES ENDOSCOPY GROUP, INC.
    Registration Number
    1528319
    FEI Number
    1000122656
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5976 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163492

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Oracle EUS Balloon (00711891) (EN-CFE) Oracle EUS latex balloon-Olympus radial (00711892) (EN-MF) Oracle EUS latex balloon-Olympus linear (00711893) (EN-MF)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device