BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CLV-S400

    Reg #: 3002808148 · FEI: 3002808148 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    SHIRAKAWA OLYMPUS CO., LTD.
    Registration Number
    3002808148
    FEI Number
    3002808148
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-1 Okamiyama, Odakura, NISHIGO-MURA
    City
    NISHISHIRAKAWA-GUN Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K151011

    Owner / Operator

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

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Bronchoscope (Flexible Or Rigid) EOQ
    Laparoscope, General & Plastic Surgery GCJ
    Laparoscope, Gynecologic (And Accessories) HET
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Nasopharyngoscope (Flexible Or Rigid) EOB

    Proprietary Names

    CLV-S400 OTV-S400

    Establishment Types

    Manufacture Medical Device