BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8 mm SureForm 30 Reload, Gray

    Reg #: 3012249465 · FEI: 3012249465 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Intuitive Surgical, Inc.
    Registration Number
    3012249465
    FEI Number
    3012249465
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    710 Venture Dr, Suite 300, DeSoto Trade Center Building 1
    City
    Southaven
    State
    MS
    ZIP
    38672
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211997

    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

    8 mm SureForm 30 Reload, Gray 8 mm SureForm 30 Curved-Tip Stapler 8 mm SureForm 30 Reload, White 8 mm SureForm 30 Stapler 8 mm SureForm 30 Reload, Blue

    Establishment Types

    Repack or Relabel Medical Device