BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    da Vinci Single-Site Instrument and Accessories

    Reg #: 3016096100 · FEI: 3016096100 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Intuitive Surgical, S. De R.L. De C.V.
    Registration Number
    3016096100
    FEI Number
    3016096100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calzada Presidente Venustiano Carranza #1745, Colonia Calles
    City
    Mexicali Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K152448

    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
    Laparoscope, General & Plastic Surgery GCJ
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    da Vinci Single-Site Instrument and Accessories

    Establishment Types

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