BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TD-TB400

    Reg #: 3002808148 · FEI: 3002808148 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    2

    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
    K211838

    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
    Instrument, Ultrasonic Surgical LFL
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    TD-TB400 TB-0520FCS TB-0535FCS SB-0545PC SB-0535IC TB-0545FCS SB-0545FC MAJ-2412 SB-0545IC TB-0920OE TD-SB400 SB-0535FC USG-410 SB-0535PC SB-0520IC SB-0520FC SB-0510IC TB-0009OF TB-0009OFX

    Establishment Types

    Manufacture Medical Device