BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8 mm SureForm 30 Reload, Gray

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INTUITIVE SURGICAL, INC.
    Registration Number
    3015612252
    FEI Number
    3015612252
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3410 Central Expressway, --
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    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

    Complaint File Establishment per 21 CFR 820.198