BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ion Reprocessing Consumable Kit

    Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    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
    K182188

    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
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Ion Reprocessing Consumable Kit Catheter Continuity Cable Planning Laptop Swivel Connector Bath Probe Leak Test Adapter PlanPoint™ Software Flexision™ Biopsy Needle 21G Reprocessing Cover Controller Flexision™ Biopsy Needle 19G Flexision™ Biopsy Needle 23G Ion™ Fully Articulating Catheter Vision Probe Adapter and Suction Adapter Ion™ Peripheral Vision Probe Catheter Guide Catheter Continuity Stand System Cart

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198