BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EndoWrist Stapler Cannula Seal

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    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
    K171388

    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
    System, Surgical, Computer Controlled Instrument NAY
    Staple, Implantable GDW

    Proprietary Names

    EndoWrist Stapler Cannula Seal EndoWrist Stapler Sheath EndoWrist Stapler Motor Pack EndoWrist Stapler Release Kit EndoWrist Stapler 45 Reload, Green EndoWrist Stapler 45 Reload, Blue EndoWrist Stapler 45 EndoWrist Stapler Cable

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198