BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SureForm 45 Curved Tip, SureForm 45 Gray Reload

    Reg #: 3017408573 · FEI: 3017408573 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Mitsui-Soko Co, Ltd
    Registration Number
    3017408573
    FEI Number
    3017408573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-3-23, Torikaikami
    City
    Settsu-city Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K190999

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US
    Correspondent
    Mario Lowe

    Products

    Device Name Product Code
    Staple, Implantable GDW
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    SureForm 45 Curved Tip, SureForm 45 Gray Reload

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device