BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Da Vinci 5 Console - Model: C5000

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    21
    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
    K232610

    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
    Insufflator, Laparoscopic HIF
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    Da Vinci 5 Console - Model: C5000 da Vinci 5 Force Feedback Large Needle Driver UPGRADE,CO2 TANK INTERFACE,CGA940,US Da Vinci 5 Robot - Model: R5000 da Vinci 5 Force Feedback ProGrasp Forceps Blue System Cable, Type B, 7m Double Receptacle System Cable Extension Kit da Vinci Insufflator Tube Set with Smoke Evacuation da Vinci 5 Force Feedback Cadiere Forceps da Vinci 5 Force Feedback Fenestrated Bipolar Forceps CABLE KIT,BLUE FIBERCONNECT,20M da Vinci Insufflator 8mm Hex Cannula, Long 8mm Endoscope, 0°, Gen5 da Vinci 5 Force Feedback Maryland Bipolar Forceps da Vinci 5 Force Feedback Mega SutureCut Needle Driver Single Receptacle System Cable Extension Kit Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5 8mm Endoscope, 30°, Gen5 Da Vinci 5 Tower - Model: T5000 8mm Hex Cannula, Standard

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198