BEUDAMED
    FDA Registration Active 🇪🇨 Ecuador

    Single-Site Monopolar Cautery , 5mm, da Vinci Si

    Reg #: 3014635169 · FEI: 3014635169 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALEM
    Registration Number
    3014635169
    FEI Number
    3014635169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vicente Duque N77-57, y Antonio Castillo
    City
    Quito Pichincha
    Country
    EC

    Regulatory Submissions

    510(k) Number
    K112208

    Owner / Operator

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

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Single-Site Monopolar Cautery , 5mm, da Vinci Si Single-Site Port for 8.5 mm Endoscope, da Vinci Si da Vinci Single-Site Instruments and Accessories Single-Site Maryland Dissector , 5mm, da Vinci Si Single-Site Bipolar Maryland, 5mm, da Vinci Si da Vinci Single-Site Port Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si Single-Site Starter Kit US, Cholecystectomy, 20 Cases Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si Single-Site Fundus Grasper , 5mm, da Vinci Si Single-Site 10 mm Accessory Cannula, da Vinci Si Single-Site 10 mm Blunt Obturator, da Vinci Si

    Establishment Types

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