BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Uro Guide

    Reg #: 3003790304 · FEI: 3003790304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GYRUS ACMI, INC.
    Registration Number
    3003790304
    FEI Number
    3003790304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    800 West Park Drive
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K830884

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Stent, Ureteral FAD

    Proprietary Names

    Uro Guide Perc Antegrade ureteral stent

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility